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RecallRegister
May, 2016
A Message from Bernie Steves, Managing Director
and Practice Leader, Crisis Management
Welcome to the May Edition of Crisis Management’s RecallRegister, Aon’s monthly recall
and product safety newsletter. This publication provides a review of the month’s recalls as
reported by the U.S. Consumer Product Safety Commission (CPSC), the U.S Food and Drug
Administration (FDA), the U.S. Department of Agriculture (USDA), National Highway Traffic
Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA). In addition
to recall announcements, RecallRegister provides an update on the product recall and
contamination insurance marketplace and environment. Each month, we highlight issues
of importance including new markets and capacity, significant recall events and changes
in legislation affecting the consumer products industry.
In this Issue
01 Pilgrim's Pride Recalls 4.5
Million Pounds of Chicken
Products
02 U.S. Department of
Transportation Expands
Takata Recall; 35-40
Millions Additional Airbags
Through 2019
03 April Recall
Announcements
Pilgrim’s Pride Recalls 4.5 Million Pounds
of Chicken Products
After approximately 40,000 pounds of chicken nuggets were recalled earlier this month,
Pilgrim’s Pride Corp. announced a recall of more than 4,500,000 pounds of fully cooked chicken
products as a result of consumer complaints that the products contained extraneous material
including metal and plastic. This nationwide recall includes more than 20 products that were
produced between August 21, 2014 to March 1, 2016. The recall affects three brands: Gold Kist
Farms, Pierce Chicken and Sweet Georgia Brand.
Despite there being no confirmed reports of adverse reactions due to the consumption of these
products, FSIS personnel identified the potentially affected product types and dates of
production after investigating additional consumer complaints of foreign material contamination
that the firm received. This investigation ultimately resulted in the most recent recall
announcement of the 4,500,000 pounds of affected product. Learn more here.
Risk. Reinsurance. Human Resources.
Aon Risk Solutions
Crisis Management Practice
RecallRegister | Aon Risk Solutions | May 2016	 2
U.S. Department of Transportation Expands Takata
Recall; 35-40 Millions Additional Airbags Through 2019
During May 2016, the U.S. Department of Transportation expanded and accelerated the Takata
air bag inflators recall to protect American drivers and passengers. This expansion was based on a
five recall phase of prioritizing risk which was determined by the age of the inflators and exposure
to high humidity and fluctuating high temperatures that accelerated the degradation of the
chemical propellant. Ruptures of the Takata inflators have been tied to ten deaths and more than
a hundred injuries in the United States. This recall decision follows the agency’s confirmation of
the root cause behind the inflators’ propensity to rupture.
Under the Amended Consent Order issued to Takata this week, the company is required to make a
series of safety defect decisions that will support vehicle manufacturer recall campaigns of an
additional estimated 30-40 million inflators. This expansion phase occurring, between May 2016
through December 2019, will add to the already 28.8 million air bag inflators previously recalled.
Also, the expansions mean that all Takata ammonium nitrate-based propellant driver and
passenger frontal air bag inflators without a chemical drying agent (also known as a desiccant) will
be recalled.
NHTSA will also consult with affected vehicle manufacturers before revising the Coordinated
Remedy Order that governs the accelerated program to obtain and install replacement inflators.
The Coordinated Remedy Program will continue to ensure that replacement inflators will be made
available to highest-risk vehicles, first. The revised Coordinated Remedy Program, which will be
announced later this summer, will detail the updated vehicle schedule with manufactures,
supplies, parts, and repairs.
Read more about the largest and most complex safety recall in U.S. history here.
In the News
April Recall Announcements
The following recalls have been announced through the U.S. Food and Drug Administration (FDA), the
U.S. Department of Agriculture (USDA), the Consumer Product Safety Commission (CPSC), National
Highway Traffic Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA).
These agencies are charged with protecting consumers from products that may pose injury to the
public. This is only a representative list of recalls announced by these agencies during the month.
A complete list of recalls, as well as actual press releases, is available at www.recalls.gov and
http://www.inspection.gc.ca/english/toce.shtml
April 1, 2016
Alimentos Congelados, S.A. Recalls
Frozen Broccoli Cuts Because of Possible
Health Risk
Alimentos Congelados, S.A. (Pinula) is
voluntarily recalling 1,800 cases of Frozen
Broccoli Cuts because it has the potential to
be contaminated with Listeria
Monocytogenes. The Frozen Broccoli Cuts
were distributed to stores in the following
states: Indiana, Kentucky, Ohio, Tennessee,
Virginia, West Virginia, Florida, Georgia,
Alabama, South Carolina and North Carolina.
The company has not received any
complaints in relation to this product and is
not aware of any illnesses associated with the
product to date. The recall was the result of
retail package of Frozen Broccoli Cuts being
tested by the State of Ohio Department of
Agriculture. The company has ceased
distribution of Frozen Broccoli Cuts, and is
fully cooperating with regulatory agencies.
Consumers who purchased the Frozen
Broccoli Cuts are urged not to consume this
product and throw it away. Consumers
requiring refund or with questions can
contact the company at 1-800-888-4646 and
ask for Consumer Affairs Monday thru Friday
between 8:00AM and 5:00 PM EST
April 4, 2016
WD Import and Export Inc. Issues an Alert
on Dried Fish Due To Possible Health Risk
WD Import and Export Inc., Brooklyn, New
York, is recalling its bulk unlabeled cardboard
boxes of Dried Yellow Fish because it has the
potential to be contaminated with
Clostridium botulinum, a bacterium which
can cause life threatening illness or death.
Botulism, a potential fatal form of food
poisoning; people experiencing these
problems should seek immediate medical
attention. The product, Dried Yellow Fish
was sold in bulk unlabeled and un-coded
cardboard boxes and is a product of China.
The product was sold in retail stores in New
York City. Consumers are warned not to
use the product even if it does not look or
smell spoiled.
No illnesses have been reported to date in
connection with this problem. Consumers
who have purchased Dried Fish are advised
not to eat it, but should return it to the place
of purchase. Consumers with questions may
contact the company at 718-567-3339. The
potential for contamination was noted after
routine sampling by New York State
Department of Agriculture and Markets Food
Inspection and subsequent analysis of the
product by Food Laboratory personnel
confirming that the fish was not properly
eviscerated prior to processing.
Eleanor Rose Recalls Children’s
Loungewear Due to Violation of
Federal Flammability Standard
Eleanor Rose, Natchez, Mississippi, has
recalled children’s loungewear as it fails to
meet federal flammability standards for
children’s sleepwear, posing a risk of burn
injuries to children. This recall affects about
5,900 unit. This recall involves two different
styles of Eleanor Rose loungewear, including
a girl’s gown and a boy or girl’s top and pants
set. The loungewear was sold in sizes 12
months through size 12. “Eleanor Rose” is
printed on a tag sewn into the neck of the
garments and on the back outside of the
pants. The style number is on a tag sewn into
the side seam or inside the back of the pants.
There are no incidents or injuries associated
with this recall. Consumers should
immediately take the recalled loungewear
away from children and return it to Eleanor
Rose for a merchandise credit towards the
purchase of another Eleanor Rose product.
April 5, 2016
Givenchy Recalls Men’s Silk T-Shirts Due to
Violation of Federal Flammability Standard
Givenchy, New York, New York, has recalled a
men’s silk t-shirt, as it fails to meet the federal
flammability standard for wearing apparel
and pose a risk of burn injury to consumers.
This recall affects about 60 units. This recall
involves three styles of Givenchy-branded
100% silk T-shirts for men. The short-sleeve
T-shirts are sheer and were sold in blue and
black plaid, black and white stripes and black
with an image of Jesus on the cross. They
were sold in sizes XXS through L. The style
number 16J7127135, 16J6218886 or
16J7205877 is printed on a tag sewn into the
side seam.
There have been no injuries or incidents
reported. Consumers should immediately
stop using the recalled T-shirts and return
them to the place of purchase for a full
refund. Givenchy is directly contacting
consumers who bought the recalled T-shirts.
Barneys New York, Givenchy Boutiques,
Maxfield and Forward, Neiman Marcus and
Nordstrom stores nationwide from February
2016 through March 2016 for between $685
and $1,350.
April 6, 2016
Granna’s LLC Issues Allergy Alert On
Undeclared Milk in French Toast
Granna's LLC is voluntarily recalling packages
of item number 808 French Toast that may
contain an undeclared milk allergen. Product
was distributed in Oklahoma through senior
nutritional sites by home delivery. The
affected product, #808 French Toast, was
labeled without milk ingredient in the
ingredient statement. The issue was
discovered by a FDA investigator during an
inspection of the recalling firm. Granna's
RecallRegister | Aon Risk Solutions | May 2016	 3
April Recall Announcements, April 1 – 6, 2016
#808 French Toast with diced potatoes and
mandarin oranges is a frozen dinner
packaged in a black, three compartment heat
sealed tray, with label located on top. This
product is a food safety concern for people
who are allergic to milk.
There have been no illnesses as of April
5,2016 reported in connection with this
product. Consumers with questions on the
recall may contact Granna's LLC at 1-580-337-
6360. Consumers would have received the
mislabeled product between April 2015 and
April 2016. Affected packages should be
discarded or returned to the place of
purchase for a refund.
Ivanka Trump Scarves Recalled by GBG
Accessories Group Due to Violation of
Federal Flammability Standard
GBG Accessories Group (formerly LF
Accessories Group, LLC), of New York has
recalled women’s scarves as they do not meet
the federal flammability standards for
clothing textiles, posing a burn risk. This
affects about 20,000 units. This recall
involves two styles of Ivanka Trump-branded
scarves, Beach Wave, in blue, coral and
yellow; and Brushstroke Oblong, in blue, red,
neutral and green. Both scarves are 76 inches
long by 24 inches wide. Scarves are 100
percent rayon with a machine-rolled hem.
A black label with “IVANKA TRUMP”
embroidered in silver is sewn on the edge
of the scarves.
There have been no incidents / injuries
reported. Consumers should immediately
stop using the recalled scarves and return
them to the place where purchased for a full
refund. Consumers who purchased the
scarves online will be contacted directly by
online retailers with return instructions.
Nipoamerican Recalls Mattresses Due to
Violation of Federal Flammability Standard
(Recall Alert)
Nipoamerican, Inc., of Marlborough,
Massachusetts, has issued a recall on all
Niposul and NipoFlorida Elegance,
Elegance Gold, and Evolution mattresses
because they fail to meet the mandatory
federal open flame standard for mattresses.
This recall involves all models and sizes of
Niposul and NipoFlorida Elegance, Elegance
Gold, and Evolution mattresses. The
Elegance and Evolution mattresses are white
and the Elegance Gold mattresses are white
with black sides. This recall affects about
325 units.
No incidents or injuries have been reported.
Niposul stores in Massachusetts and
NipoFlorida stores in Florida from July 2014
through October 2015 for between $1,200
and $6,500. Consumers should contact
Niposul or NipoFlorida for free mattress
covers to bring the mattress into compliance
with the federal standard and protect
consumers from a fire. Assistance with
installation is available upon request.
April 7, 2016
Country Favor Issues Allergy Alert on
Undeclared Peanuts in "Best Taste Keo
Me Den Candy"
Country Favor Inc., Maspeth, New York, is
recalling its 120g packages of "Best Taste Keo
Me Den Candy" food treats because they
contain undeclared peanuts. The recalled
"Best Taste Keo Me Den Candy" was
distributed nationwide in retail stores. The
product comes in a 120g clear and green
plastic bag with an expiration date of 2017-12
stamped at the bottom.
No Illnesses have been reported to date in
connection with this problem. The recall was
initiated after routine sampling by New York
State Department of Agriculture and Markets
Food Inspectors and subsequent analysis of
the product by Food Laboratory personnel
which revealed the presence of peanuts in
packages of Best Taste Keo Me Den Candy
that did not declare its presence. Consumers
who have purchased 120g packages of "Best
Taste Keo Me Den Candy" are urged to return
them to the place of purchase for a full
refund. Consumers with questions may
contact the company at 718-418-9400.
Michel Et Augustin Inc. Issues Allergy
Alert on Undeclared Hazelnuts in Petites
Baguettes Butter Cookies Dark Chocolate
Michel et Augustin Inc., Brooklyn, NY, is
recalling approximately 900 packages of its
Petites baguettes butter cookies Dark
Chocolate, 6 packs only, because they may
contain undeclared hazelnuts. Michel et
Augustin Petites baguettes butter cookies
Dark Chocolate were distributed to retail
stores throughout New York City.
No illnesses or complaints have been
reported to date.The recall was initiated after
the firm discovered packages that had visible
pieces of nuts on top of the butter cookies.
Subsequent investigation by the firm and
foreign manufacturer revealed that a small
quantity of packages of the milk chocolate
and hazelnut recipe were incorrectly packed
into Dark chocolate packages, and hazelnuts
are not listed on the label.
Consumers who have purchased Michel et
Augustin Petites baguettes butter cookies
Dark Chocolate, 6 packs, with Best before
date 07 2016 and are allergic to hazelnuts
should not consume this product. Consumers
are urged to return the product to the place
of purchase for a full refund. Consumers with
questions should contact the company at
1-646-820-0935, Monday - Friday, 9 am –
6 pm, EDT.
GolfBuddy GPS Bands Recalled by Deca
International Due to Burn Hazarde
Deca International Corp., dba GolfBuddy,
of La Palma, California, has issued a recall
because the band charging ports can
produce an electrical charge to exposed skin,
posing a burn hazard to consumers. This
recall involves GolfBuddy BB5 golf GPS LED
bands. The band is a wearable GPS unit that
operates as a pedometer, distance monitor
and watch and comes preloaded with golf
course information. It is made of plastic with
a stainless steel casing, has a LED display
screen and a two-pronged connector at the
end for closure. The display screen is flush
with the top side of the band and has four
buttons on the perimeter of the band. The
model BB5 is on the back of the recalled unit
below the charging port. Recalled units do
not have a yellow round sticker on the front
and on the packaging.
The firm has received two reports of
consumers being burned. This recall affects
about 3,000 units. Consumers should
immediately stop using the recalled golf
wristbands and contact GolfBuddy for
instructions on how to update the unit with
the latest firmware, also available in the
firm’s website.
IKEA Recalls Children’s Bat Cape Costumes
Due to Strangulation Hazard
IKEA North America Services LLC, of
Conshohocken, Pennsylvania, has recalled
children’s bat cape costume due to the fabric
hook and loop fastener at the neck of the bat
cape can fail to detach readily during use,
posing a strangulation hazard to children.
This recall affects about 11,000 units. This
recall involves IKEA children’s bat cape
costumes. The capes are black with gray
stripes, 100% polyester, measure 30 inches
long by 57 inches wide and have a fabric
hook and loop fastener closure at the neck.
IKEA, LATTJO and numbers 60311650 and
18937 are printed on a white label sewn into
the seam of the cape.
RecallRegister | Aon Risk Solutions | May 2016	 4
April Recall Announcements, April 6 – 7, 2016
IKEA has received three reports outside of the
United States of the fabric hook and loop
fastener at the neck of the costume failing to
detach readily and scratching children’s
necks. Consumers should immediately take
the recalled bat capes away from children
and return the capes to any IKEA store for a
full refund. IKEA stores nationwide and online
at www.ikea-usa.com from November 2015
through February 2016 for about $13.
April 8, 2016
Voluntary Recall of Fetch™ 2 Aspiration
Catheter
Boston Scientific, Marlborough,
Massachusetts, has initiated a global,
voluntary recall of all models of its Fetch™ 2
Aspiration Catheter, a thrombectomy
catheter used during procedures to remove
small blood clots from coronary arteries. The
Fetch 2 catheters were recalled on March 22,
2016, due to complaints of shaft breakage.
The U.S. Food and Drug Administration (FDA)
classified the action as a Class 1 recall. This
recall designation means that the use of the
device exposes the patient to a reasonable
chance of a serious adverse health
consequence or death.
There have been no reports of patient injury
or death, and there is no risk to patients who
previously underwent a thrombectomy
procedure with the Fetch 2 catheter. All
reports of shaft breakage happened during
the procedure, and the broken section was
either removed while still partially attached
to the catheter shaft or retrieved with a snare,
without further patient complications. While
unreported, the most severe potential
outcome of this breakage is embolism of
device fragments, which could lead to
obstruction of blood flow or additional
intervention to remove a device fragment
surgically.
Because Boston Scientific acquired the Fetch
2 catheter product line from Bayer Medical
Care Inc., all recalled inventory is packaged
and labeled as Bayer product. This device
was manufactured between June 11, 2014
and February 19, 2016. There are currently
21,155 devices on the market subject to this
recall.Physicians and healthcare facilities can
direct questions to their Boston Scientific
representative or, call 1-800-811-3211.
Adverse reactions or quality problems
experienced with the use of this product may
be reported to the FDA MedWatch Adverse
Event Reporting program either online, by
regular mail or by fax.
April 10, 2016
Progressive Gourment Inc. Issues an
Allergy Alert on Taste of Inspirations
Edamame Rangoon Due to Possible
Mislabeling and Undeclared
Crustacean Shellfish
Progressive Gourmet Inc., Wilmington,
Massachusetts, is voluntarily recalling its
frozen, 9 ounce packages of Taste of
Inspirations Edamame Rangoon out of an
abundance of caution because they have the
potential to contain crustacean shellfish
(crab). People who have an allergy to
crustacean shellfish run the risk of serious
or life-threatening allergic reaction if they
consume these products. The item is
produced for Hannaford Supermarkets.
The potentially impacted Edamame
Rangoon were possibly sold to consumers
at select Hannaford stores located in Maine,
Massachusetts, New Hampshire, Vermont
and New York. A consumer reported the
mislabeling incident. The firm has initiated
prompt corrective actions to prevent
future mislabeling.
No illnesses have been reported to date in
connection with this product.Consumers
who have purchased 9 ounce packages of the
edamame rangoon are urged to return them
to the place of purchase for a full refund.
Consumers with questions may contact the
company at 1-800-224-7630 (9:00 am – 5:00
pm Monday through Friday EST).
Reser's Fine Foods, Inc. Recalls
Refrigerated Salads Because of Possible
Health Risk Due to Onion Supplier Recall
Reser's Fine Foods, Inc., Beaverton, Oregon is
recalling nineteen refrigerated salad items
due to notification from one of our ingredient
suppliers that Listeria monocytogenes may
be present in one lot of onions that was used
in the manufacture of these salads. Listeria
monocytogenes is an organism which can
cause serious and sometime fatal infections in
young children, frail or elderly people and
individuals with weakened immune systems.
Healthy people may suffer only short term
symptoms such as high fever, severe
headache, stiffness, nausea, abdominal pain
and diarrhea. Listeria infection can cause
miscarriages and stillbirths among pregnant
women. The retail product is sold in plastic
containers and is marked with a Use By Date
and the #10 at the end of the line of printing
(see photo below).
No illnesses have been reported to date.
The recall was the result of a notification
from one of our onion suppliers that the
bacteria may be present in one lot of onions
used in the manufacture of these refrigerated
salads. No other items were manufactured
using this lot of onions. Consumers are urged
not to consume these products. Consumers
who purchased these products may take
them back to the store for a refund or
discard them.
April 11, 2016
Super Herbs Issues Voluntary
Nationwide Recall Of SUPER HERBS
Due To Presence Of Undeclared
Sibutramine, Desmethylsibutramine
and/or Phenolphthalein
Super Herbs is voluntarily recalling all bottles
of SUPER HERBS, light green and dark green
capsules to the consumer level after FDA
laboratory testing found SUPER HERBS to
contain sibutramine, desmethylsibutramine,
and/or phenolphthalein. The product is used
as a weight loss dietary supplement and is
packaged in clear bottle with light green and
dark green capsules.
Super Herbs has not received any reports if
adverse events related to this recall. The
affected Super Herbs product includes all
bottles which have been distributed
nationwide to consumers via internet www.
mysuperherbs.com. Super Herbs is notifying
its customers by Email and is arranging for
return. Consumers who are currently in
possession of recalled Super Herbs light
green and dark green capsules should stop
using the product and contact Super Herbs.
SUPER HERBS will be discontinued.
EBB (U.S.) Inc. (English Bay Batter)
Issues Voluntary Allergy Alert for PICs
by Price Chopper Cinnamon Rolls with
Cream Cheese Icing due to Incorrect
Allergen Caution
EBB (U.S.) Inc., Columbus, Ohio, is voluntarily
recalling 97 cases of PICs by Price Chopper
Cinnamon Rolls with Cream Cheese Icing
(UPC 041735073389) because, although milk
was listed in the ingredients list, it was
mentioned in the wrong allergen caution.
This voluntary recall has been issued by EBB
(U.S.) Inc. out of an abundance of caution to
protect consumers who might be at a risk
from exposure to milk.
To date, there have been no reports of illness
in connection with use of this product. The
RecallRegister | Aon Risk Solutions | May 2016	 5
April Recall Announcements, April 7 – 11, 2016
recall was initiated after it was discovered
that the product label on the dairy-
containing product listed milk as an
ingredient but used the wrong allergen
cautionary language. Consumers affected
by this recall should immediately discard
the product. Consumers with any questions
should contact the company at 1-800-253-
6844 Monday through Friday, 9-4:30
Pacific Time.
Back to Nature Issues Allergy Alert for
Limited Number of Classic Crème Cookies
Due to Undeclared Milk
Back to Nature Foods, LLC, Naples, Florida, is
voluntarily recalling two (2) lots of its Classic
Crème cookies, 12 oz packages, because it
may contain undeclared milk, not listed as an
ingredient on the label. The affected product
was distributed to retail stores nationwide.
Packages are marked with a unit UPC #19898-
01103 and with best by dates of 10 SEP 16
and 16 SEP 16 labeled on top of the package.
No other best by dates are affected.
Consumers who have purchased the Back to
Nature Classic Crème cookies with the UPC
and dates noted, and have an allergy to milk,
should destroy the product they have or are
urged to return to the place of purchase for
product replacement or refund.
This voluntary recall is being conducted with
the knowledge of the U.S. Food & Drug
Administration. No other Back to Nature
brand products are included in this recall.
Consumers with questions may call Back to
Nature’s Consumer Relations Center at 844-
275-5845. The center is open Monday
through Friday from 9:00 a.m. to 5:00 p.m.
Eastern. Consumers also may contact the
center via e-mail by visiting the Contact Us
page at http://www.backtonaturefoods.com
for a replacement coupon.
Dexcom, Inc., Issues Press Release
to Supplement Previous Customer
Notification
Dexcom, Inc., San Diego, California, issues
this press release to supplement its previous
customer notification and remind its patients
to periodically test the audible alarms and
alerts on certain receivers manufactured by
Dexcom to make sure that the audible alarms
and alerts are functioning properly. The
notification constituted a voluntary recall and
applied to those Dexcom G4 Platinum
Receivers, Dexcom G4 Platinum Pediatric
Receivers, Dexcom G4 Platinum Professional
Receivers, Dexcom G4 Platinum with Share
Receivers, Dexcom G4 Platinum with
Share Pediatric Receivers and the Dexcom
G5 Mobile Receivers that are experiencing
problems with audible alarms and alerts.
There is no reason for patients to return
receivers to Dexcom that are functioning
properly.
Dexcom issued the customer notification on
February 23, 2016 via its website and certified
mail to patients. The notification alerted
customers of a potential issue affecting the
audible alarms and alerts associated with the
speaker component of certain receivers.
Dexcom notified customers about this
potential issue after receiving customer
complaints about the receivers' speaker
component. Specifically, the speaker failed to
properly provide audible alerts and alarms in
some or all instances.
Customers who rely on audible alerts and
alarms may not be notified of severe
hypoglycemia or hyperglycemia if the
speaker in their receiver does not function
properly. The immediate health
consequences of severe hypoglycemia
include loss of consciousness, seizure, and
in rare instances death.
Whole Foods Market Recalls Mislabeled
Asparagus, Pea and Ricotta Salad Due
to Undeclared Allergen
Whole Foods Market is recalling ten ounce
packages of Asparagus, Pea and Ricotta salad
because it was mislabeled and actually
contained miniature Asparagus, Sun Dried
Tomato and Swiss Frittatas. Due to the
labeling error, an egg allergen was
undeclared. The product was produced at
the Whole Foods Market North Atlantic
Kitchen in Everett, Massachusetts.
No illnesses or reactions have been reported.
The recalled product (UPC Code 0 36406
30344 5) contains frittatas and has a "sell by"
date of April 14, 2016 and was sold on
Sunday, April 10, 2016 at fourteen Whole
Foods Market. Signage is posted in affected
Whole Foods Market stores to notify
customers of this recall. Consumers who have
purchased this product from Whole Foods
Market may return it to the store for a full
refund. Consumers with questions should
contact their local store or call 617-492-5500
between the hours of 9am and 5pm EST.
April 12, 2016
Coleman Recalls Flashlights Due to
Fire Hazard
Coleman® CTAC Lithium-Ion Flashlights have
been recalled due to the lithium-ion batteries
can overheat, posing a fire hazard to
consumers. This affects about 8,500 in the
United States (in addition, about 500 were
sold in Canada). This recall involves three
models of Coleman® CTAC Lithium-Ion
Flashlights. Models include CTAC20 (model
2000013874), CTAC40 (model 2000013873)
and CTAC60 (model 2000013872). The
flashlights are black, with “Coleman” printed
in white along the handle and have the
model number in white print on the upper
portion of the handle next to the light. The
flashlights are 6.5 inches long. The
lithium-ion batteries inside the flashlights are
red with the Coleman logo printed in white
on the battery.
Coleman has received two reports of the
flashlight batteries overheating, catching fire
and causing minor property damage. No
injuries have been reported. Consumers
should immediately stop using the recalled
flashlights and contact Coleman for
instructions on returning the flashlights for a
full refund.
April 13, 2016
Hospira Issues A Voluntary Recall For One
Lot Of 50% Magnesium Sulfate Injection,
USP Due To The Presence Of Particulate
Hospira, Inc., a Pfizer company, is voluntarily
recalling one lot of 50% Magnesium Sulfate
Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL
Single-dose vials, Lot 50-343-DK, Expiration
01FEB2017, NDC 0409-2168-02, to the
hospital level due to a confirmed customer
complaint for the presence of particulate
matter, within one single-dose fliptop vial. A
recall was previously executed for this lot on
March 23, 2016 due to a confirmed high out
of specification (OOS) result for pH.
If the particulate is detected prior to
dispensing or administration to a patient,
patient harm is unlikely. If the delay of
therapy is prolonged, there is the potential
for serious medical consequences for mother
and fetus requiring medical intervention. If
the particulate is not observed prior to
administration, it may result in localized
swelling, redness, pain at the site of
administration or veins, allergic reactions to
RecallRegister | Aon Risk Solutions | May 2016	 6
April Recall Announcements, April 11 – 13, 2016
the foreign particle, microembolic effects as
well as possible fetal harm. The likelihood of
serious patient harm is considered low due to
high-detectability of this non-conformance.
To date, Hospira has not received reports of
any adverse events associated with this issue
for this lot. Hospira places the utmost
emphasis on patient safety and product
quality at every step in the manufacturing
and supply chain process. This recall is being
executed with the knowledge of the U.S.
Food and Drug Administration.
April 14, 2016
A&S Food Trading Inc. Issues Alert on
Undeclared Sulfites in Gorgeous
Memory Daylily
A&S Food Trading Inc., Brooklyn, New York
is recalling its 10.6 ounces (300 grams)
packages of Gorgeous Memory Daylily
because they contain undeclared sulfites.
Consumers who have severe sensitivity to
sulfites run risk of serious or life-threatening
allergic reaction if they consume this
product. The product comes in 10.6 ounces
(300 grams) clear plastic bag. Gorgeous
memory Daylily in 10.6 ounces (300 grams)
packages was distributed in New York City
area, and has reached consumers through
retail stores.
The recall was initiated after routine sampling
by New York State Department of Agriculture
and Markets Food Inspector and subsequent
analysis by Food Laboratory personnel
revealed the presence of sulfites in the 10.6
ounces (300 grams) package of Gorgeous
memory Daylily, which were not declared on
the label. The consumption of 10 milligrams
of sulfites per serving has been reported to
elicit severe reactions in some asthmatics.
No illnesses or allergic reaction involving this
product have been reported to date.
Consumers who have purchased 10.6 ounces
(300 grams) packages of Gorgeous memory
Daylily are urged to return them to the place
of purchase for full refund. Consumers with
questions may contact the company at
718-369-2648.
Thomas Star Bakery of Ohio LLC Issues
Voluntary Recall on Buns Bread
Thomas Star Bakery of Ohio LLC, is voluntarily
recalling Buns Bread, which contains
undeclared allergens. The bread product
contains milk and eggs, known allergens
which are not declared on the label. The Buns
Bread product was available for purchase
between the dates of August 2015 and April
13, 2016. No other Thomas Star Bakery of
Ohio products are involved in this recall.
Ohio Department of Agriculture and the
company have received no reports of adverse
reaction due to consumption of this product.
Anyone concerned about an injury or illness
should contact a healthcare provider.The
missing allergen information was discovered
by the Ohio Department of Agriculture
during an inspection of the recalling firm.
Product involved in this recall can be
brought to the place of purchase for a refund.
Consumers with questions on the recall
may contact Thomas Star Bakery of Ohio
at (419) 214-0711.
Sugarfina Issues Allergy Alert on
Undeclared Peanuts in Milk Chocolate
Malt Balls
Sugarfina LLC, Ingelwood, California, is
voluntarily recalling 742 units of its Sugerfina
Milk Chocolate Malt Balls (UPC Code
840278113565, SKU K1159) because it may
contain undeclared peanuts. People who
have an allergy or severe sensitivity to
peanuts run the risk of serious or life-
threatening allergic reaction if they consume
these products. The Sugarfina Milk Chocolate
Malt Balls are packaged in 2" acrylic cubes.
The product is pictured below. The UPC
Code 840278113565 and SKU K1159 appears
on the back panel of the label.
No illnesses have been reported to date. The
recall was initiated after it was discovered
that some Sugarfina Peanut Butter Malt Balls
had been mixed in with a batch of Sugarfina
Milk Chocolate Malt Balls. Consumers who
have purchased Sugarfina Milk Chocolate
Malt Balls are urged to discard the product or
return it to the place of purchase. Consumers
with questions may contact the company at
855-784-2734 from 8AM to 5PM, PST,
Monday-Friday.
OLMA-XXI, Inc. Recalls Norven Herring in
Oil Because of Possible Health Risk
OLMA-XXI, Inc., Brooklyn, New York, is
recalling Norven herring in oil, Lot 530611,
because it has the potential to be
contaminated with Listeria monocytogenes,
an organism which can cause serious and
sometimes fatal infections in young children,
frail or elderly people, and others with
weakened immune systems.
No illnesses have been reported to date. The
recall is the result of sampling and testing by
the U.S. Food and Drug Administration (FDA)
which revealed the presence of Listeria
monocytogenes in the 17.6 oz. (500g)
packages of NORVEN Herring in oil, Lot #
530611. The distribution of the product has
been suspended while FDA and the company
continue to investigate the source of the
problem. Consumers who have purchased
plastic containers of Norven herring in oil, Lot
530611, are urged not to consume this
product and to return it to the place of
purchase for a full refund. Consumers with
questions may contact the company at 1-718-
675-0706, Monday - Friday, 8 am - 6 pm, EDT.
April 15, 2016
Back to Nature Expands Voluntary Recall
for Limited Number of Classic Creme
Cookies Due to Undeclared Milk
Back to Nature Foods, LLC, Naples, Florida, is
expanding its voluntary recall to include four
(4) additional lots of its Classic Creme
cookies, 12 oz packages, because they may
contain undeclared milk, not listed as an
ingredient on the label. Persons who have an
allergy or severe sensitivity to milk run the
risk of a serious or life-threatening allergic
reaction if they consume this product. The
affected product was distributed to retail
stores nationwide. In addition to the
previously announced affected packages that
were marked with a unit UPC# 19898-01103
and with best by dates of 10 SEP 16 and 16
SEP 16 labeled on top of the package, Classic
Creme cookies packages marked with a unit
UPC# 19898-01103 and with best by dates of
13 AUG 16 and 08 OCT 16 and 21 OCT 16
and 22 OCT 16 labeled on top of the package
were also affected.
Consumers who have purchased the Back to
Nature Classic Creme cookies with the UPC
and dates noted, and have an allergy to milk,
should destroy the product they have or are
urged to return to the place of purchase for
product replacement or refund. No other
best by dates are affected. Consumers with
questions may call Back to Nature’s Consumer
Relations Center at 844-275-5845. The center
is open Monday through Friday from 9:00
a.m. to 5:00 p.m. Eastern. No other Back to
Nature brand products are included in this
recall. This voluntary recall is being
conducted with the knowledge of the U.S.
Food & Drug Administration.
RecallRegister | Aon Risk Solutions | May 2016	 7
April Recall Announcements, April 13 – 15, 2016
Mary's Home Canning Recalls Mary's
Home Made Vegetable Soup Because of
Possible Health Risk
Mary's Home Canning, Lancaster,
Pennsylvania, is recalling 516 jars of Mary's
Homemade Vegetable Soup (Net Wt. 16 OZ)
and 1,128 jars of Mary's Homemade
Vegetable Soup (Net Wt. 32 OZ), because it
has the potential to be contaminated with
Clostridium botulinum, a bacterium which
can cause life-threatening illness or death.
Consumers are warned not to use the
product even if it does not look or smell
spoiled. Botulism, a potentially fatal form of
food poisoning; people experiencing these
problems should seek immediate medical
attention.
No illnesses have been reported to date. The
potential for contamination was noted after
FDA testing found that the pH of the product
was high and it did not receive an adequate
process time or temperature. Anyone with a
product fitting the above description should
return the product to where it was
purchased, if possible, or call Mary's Home
Canning at 717-442-8349 for return
instructions. Phone calls should be made
during Eastern Standard Time.
April 18, 2016
Midwest International Corp Issues Allergy
Alert on Undeclared Milk in Hosdo Cake
Midwest International Corp, Brooklyn, New
York, is recalling HOSDO CAKE because it
contains undeclared milk. Consumers who
have allergies to milk run the risk of serious or
life-threatening allergic reactions if they
consume this product. In addition, this
product was found to contain an unallowed,
unidentified green/yellow fluorescent dye.
The recalled HOSDO CAKE comes in a blue
and white plastic wrapped, 7
ounce(200gram) package. All manufacturer
and expiration date codes are affected. It was
sold in New York City.
No illnesses have been reported to date in
connection with this product. Consumers
who have purchased HOSDO CAKE should
not consume it, but should return it to the
place of purchase. Consumers with questions
may contact the company at 646-388-3032.
The recall was initiated after it was discovered
through routine sampling by New York State
Department of Agriculture and Markets Food
Inspectors and subsequent analysis of the
product by Food Laboratory personnel
revealed the presence of milk in packages of
HOSDO CAKE which did not declare milk as
an ingredient on the label.
April 19, 2016
Exceptional Health Products Issues
Allergy Alert On Undeclared Soy And Milk
Allergens In Angel Wings™- Daily Multi
120 Capsules
Exceptional Health Products, Tulsa,
Oklahoma, is recalling Angel Wings™ - Daily
Multi 120 Capsules because this product
contains undeclared SOY and MILK allergens.
People who have an allergy or severe
sensitivity to Soy or Milk allergens run the risk
of serious or life-threatening allergic reaction
if they consume this product. The following
product was distributed nationwide to
consumers through mailorder. This voluntary
recall has been initiated because this product
contains undeclared SOY and MILK allergens.
No illnesses have been reported to date. This
was brought to our attention by the Food
and Drug Administration that found
inconsistencies with our supplier’s allergen
statement on the Amino Acid ingredients
used in this formulation. If you find the
recalled lot numbers on the bottom of any
bottle you have inventory you may return it
to the address at the bottom for a full refund
or replacement. If you have further
distributed this product, please identify the
recipients or your customers and notify them
at once of this product recall.
Nuvi Global Corporation Issues Allergy
Alert on Undeclared Milk and Soy in
StemVitae 30oz Liquid Multivitamin
Nuvi Global Corporation, Rancho
Cucamonga, California, is recalling StemVitae
30oz liquid multivitamin because it contains
undeclared milk and soy lecithin. People who
have an allergy or severe sensitivity to milk or
soy run the risk of serious or life-threatening
allergic reaction if they consume this
product. The brand is Nuvi Global with a
white and orange label that has the name
StemVitae. The label contains an image of
various fruits and vegetables. The lot number
is 15556 and can be found printed in black
ink underneath the bottle.
No illnesses have been reported to date. The
recall was initiated after it was discovered by
the FDA that the ingredient whey protein was
not declared on the label. The whey protein
ingredient contains the allergens of milk and
soy lecithin.
Consumers who have purchased StemVitae
liquid multivitamin are urged to return it to
the company. Consumers with questions may
contact the company at 844-740-6838
between the hours of 7:00am and 6:50pm
PST Monday-Friday.
April 20, 2016
Medtronic Announces Worldwide
Voluntary Recall for Battery Pack
In Covidien Oridion Labeled
Capnostream™20 and Capnostream™
20p Patient Monitors
Medtronic is notifying customers worldwide
of a voluntary recall for the battery pack used
in its Covidien Oridion labeled
Capnostream™20 and Capnostream™20p
Patient Monitors. This voluntary recall is
being conducted due to a battery
manufacturing defect that may increase the
risk of thermal damage in the battery pack.
The scope of this recall includes battery pack
model numbers 016400 and 010520. These
packs were manufactured by a contract
manufacturer between April 2014 and
February 2016. Capnostream monitors are
external (non-implantable) medical devices
used to assess patients’ respiratory status and
identify changes in breathing. The
prescription device is operated by trained
healthcare professionals in a clinical setting
and in the home.
Medtronic has received seven reports of
thermal damage out of 9,817 battery packs
impacted by this field action. Of these seven
reports, one involved a fire resulting in smoke
inhalation and minor burns. On April 15,
2016, Medtronic sent a letter to customers
who have Capnostream battery packs
affected by this voluntary recall. The
Company also supplied a rework kit with full
instructions for removal and proper disposal
or recycling of the battery pack according to
local policy. The eight cell, 14.3 volt, Lithium
Ion battery pack is custom manufactured by
third party contract manufacturers.
The company recommends that customers
use the Capnostream monitors on AC power
(with the battery pack removed) until a
replacement battery pack is available. The
company has identified a manufacturing
change conducted by the third party
contract manufacturer as the probable root
cause and is manufacturing new batteries
that meet original specifications with a new
contract manufacturer. The company will
supply new batteries to affected customers
RecallRegister | Aon Risk Solutions | May 2016	 8
April Recall Announcements, April 15 – 20, 2016
when available. No other Medtronic products
are affected by this supplier of battery packs.
Medtronic has contacted the FDA and other
regulatory bodies to share information
related to this issue. The company will
continue working directly with government
authorities and customers on this
voluntary recall.
April 21, 2016
Urgent Product Recall for Undeclared Soy
and Milk Allergens
MagZuma Nutrition , Tulsa, Oklahoma, is
recalling effected lots of it’s Life’s Qik Fix™ and
Zuma Supreme™ products because they
contain undeclared soy and milk allergens.
People who have an allergy or severe
sensitivity to Soy or Milk allergens run the risk
of serious or life-threatening allergic reaction
if they consume this product. No illnesses
have been reported to date and there are no
other product concerns except for people
that have Soy or Milk allergies. This voluntary
recall has been initiated by Magzuma
Nutrition because the Food and Drug
Administration brought to our attention
inconsistencies they found with our supplier’s
allergen statement on the Amino Acid
ingredients used in this formulation.
The Zuma Supreme lot numbers began
shipping nationwide on December 23,
2014 and the Life’s Qik Fix on February 8,
2016. If you find the recalled lot numbers on
the bottom of any bottle you have in
inventory you may return it to the address at
the bottom for a full refund or replacement.
If you have further distributed this product,
please identify the recipients or your
customers and notify them at once of this
product recall. If you have any questions,
call 888-306-8855 Monday thru Friday
8:00 AM to 5:00 PM CST. We are sorry for
this inconvenience and appreciate your
assistance.
April 22, 2016
CSM Bakery Solutions Issues Allergy Alert
on Undeclared Peanut in Chick-Fil-A
Chocolate Chunk Cookies
CSM Bakery Solutions, Atlanta, Georgia, is
voluntarily recalling Chick-fil-A Chocolate
Chunk Cookies because they may contain low
levels of undeclared peanut. The recalled
products were distributed through Chick-fil-A
Restaurants. The recall was initiated after it
was discovered by CSM during post-
production testing that flour containing
low-levels of undeclared peanut as a result of
incidental contact was provided by a supplier
to CSM Bakery Solutions. The flour was used
in products distributed by CSM in packaging
that did not reveal the presence of peanut.
No illnesses have been reported to date.
Consumers and wholesale customers who
have purchased the product are urged to
return it to the place of purchase for a full
refund. Consumers with questions may
contact CSM Bakery Solutions at 1-800-241-
8526 extension 4, option 3. Calls can be
made to this office during normal business
hours (EST) during the week.
April 23, 2016
CRF Frozen Foods Recalls Frozen
Vegetables Due to Possible Health Risk
CRF Frozen Foods, Pasco, Washington, is
voluntarily recalling fifteen frozen vegetable
items that have the potential to be
contaminated with Listeria monocytogenes.
The Listeria was discovered through routine
testing by state health officials in Ohio.
Listeria monocytogenes was found to be
present in one lot of Individually Quick
Frozen (IQF) organic petite green peas and
one lot of IQF organic white sweet cut corn.
No illnesses have been reported to date, but
the company is recalling the products as a
precaution. Consumers are urged not to
consume these products. Consumers who
purchased these products may take them
back to the store where they purchased them
for a refund or simply discard them.
Consumers seeking information may call
1-844-483-3866 Monday through Friday,
8:00 am to 5:00 pm Pacific Standard Time.
April 25, 2016
Fresenius Kabi Issues Voluntary
Nationwide Recall of Sensorcaine® -MPF
(bupivacaine HCl) Injection, USP due
to the Presence of Particulate Matter
Characterized as Glass
Fresenius Kabi USA announced today it is
voluntarily recalling a single lot of
Sensorcaine®-MPF (bupivacaine HCl)
Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in
a 30 mL vial because due to visible particulate
matter characterized as glass observed.
Administration of a solution containing glass
particulate matter by the epidural or
retrobulbar (behind the eyeball) route may
result in inflammation and injury, or cause
blockage of vasculature around the eye or
emboli in the vasculature of eye nerves. The
recalled product is labeled with Product
Code 470237 and Lot Number 6111504 and is
supplied as 0.75% strength in a 30 mL single
dose flint molded vial and packaged in units
of 25. The product was shipped in the United
States to wholesaler and distributor outlets
between March 4, 2016 and March 21, 2016
and has an expiration date of September
2019. The NDC number for this product is
63323-472-37.
To date, Fresenius Kabi has not received any
reports of adverse events related to this
recall. Fresenius Kabi is notifying its
distributors and customers by letter and is
arranging for return of all recalled product. If
health care facilities have the affected lot,
they are to immediately discontinue
distributing, dispensing or using the lot and
return all units to Fresenius Kabi. Distributors
are instructed to immediately notify their
customers that have been shipped, or may
have been shipped the product involved in
this recall and direct them to discontinue
distributing, dispensing or using the affected
lot and return the product to Fresenius Kabi.
Consumers with questions regarding this
recall can contact Fresenius Kabi at 1-800-
551-7176 Monday through Friday, during the
hours of 8:00 a.m. to 5:00 p.m.
Old Home Kitchens Issues Allergy Alert
and Voluntary Recall on Undeclared
Peanuts in "Old Home Kitchens 14oz
Sliced Creme Cakes"
Old Home Kitchens, Bogart, Georgia, is
voluntarily recalling “Old Home Kitchens
14oz. Sliced Lemon Crème Cake production
code 16104 UPC 7121405521”, “Old Home
Kitchens 14oz. Sliced Vanilla Crème Cake
production code 16104 UPC 7121405520”,
and “Old Home Kitchens 14oz. Sliced
Strawberry Swirl Crème Cake with a
production code of 16098 UPC 7121405522”,
due to a potential presence of peanut
allergen in a CSM Bakery Solutions supplied
ingredient. People who have allergy or
sensitivity to peanuts run the risk of serious or
life threatening allergic reaction if they
consume these products. The production
codes can be found ink jet coded on the
plastic clam shell packages.
No Illnesses have been reported to date. The
recall was initiated after Old Home Kitchens
was informed by their ingredient supplier,
CSM Bakery Solutions, an ingredient used in
manufacturing the recalled products was
potentially contaminated with an undeclared
peanut allergen. The product packaging does
not reveal the presence of peanuts. The
RecallRegister | Aon Risk Solutions | May 2016	 9
April Recall Announcements, April 20 – 25, 2016
recall was initiated after Old Home Kitchens
was informed by CSM Bakery Solutions that an
ingredient supplied to Old Home Kitchens
contained a peanut allergen. These Crème
Cakes do not reveal the presence of peanuts.
Old Home Kitchens has alerted the distributers
of these retailers, which have removed this
product from stores. The recall is being made
with the knowledge of the U. S. Food and
Drug Administration. Consumers who have
purchased “Old Home Kitchens 14oz Sliced
Crème Cake” with the codes noted above are
urged to return it to their Retail Stores for
product replacement or refund. No other
“Old Home Kitchens” product is included in
this recall.
Krasnyi Oktyabr USA Inc. Recalls Vobla
(Roach) Dry Eviscerated Salted Fish and
Bream Dry Eviscerated Salted Fish Due to
Possible Health Risk
Krasnyi Oktyabr Inc., Brooklyn, New York, is
recalling Vobla (Roach) Dry Eviscerated Salted
Fish and Bream Dry Eviscerated Salted Fish
because they have the potential to be
contaminated with Clostridium botulinum, a
bacterium which can cause life threatening
illness or death. Consumers are warned not to
use the products even if they do not look or
smell spoiled. The products were imported
from Russia and sold to retail stores in New
York and California from February through
April 2016.
No illnesses have been reported to date in
connection with this problem. The potential
for contamination was noted after routine
sampling and inspection by the US Food and
Drug Administration and subsequent analysis
of the Bream fish by the FDA confirmed that
the Bream fish was not properly eviscerated
prior to processing. Consumers who have
purchased Vobla Dry Eviscerated Salted Fish
and Bream Dry Eviscerated Salted Fish are
advised not to eat them, but should return
them to the place of purchase. Consumers
with questions may contact the company at
718-858-6720, Monday – Friday, 9 am –
4 pm EDT.
April 26, 2016
Schaffner Distributing Pronutri LLC. Issues
an Allergy Alert on Undeclared Soy Lecithin
and Milk in Re-VITA-lize
Schaffner Distributing Pronutri LLC. is recalling
Re-VITA-lize LOT #15554, because it contains
undeclared SOY Lecithin and MILK ingredient.
People who have an allergy or severe
sensitivity to SOY OR MILK ingredients may
run the risk of serious or life-threatening
allergic reaction if they consume these
products. Re-VITA-Lize was distributed
through retail stores and direct delivery to the
following states, California, Washington,
Oregon, Minnesota, Texas, and Iowa. The
product is packaged in a 32oz white plastic
bottle with the name Re-VITA-Lize Tropical
Orange Flavor The lot number, lot #15554, can
be found on the side of the bottle.
No illnesses have been reported to date. The
recall was initiated after it was discovered by
FDA that the product contained undeclared
whey protein which contains the allergens of
milk and soy lecithin. Consumers who have
purchased Re-VITA-Lize are urged to return it
to the place of purchase for a full refund.
Consumers with questions may contact the
company at 1-866-688-7220 Monday–Friday
8am to 5pm PST.
Glenn Wayne Wholesale Bakery Issues
Allergy Alert on Undeclared Peanuts in
Select 7-Eleven Fresh To Go Cookies
Glenn Wayne Wholesale Bakery of Bohemia,
New York, is recalling select 7-ELEVEN FRESH
TO GO brand cookies because they may
contain undeclared peanuts. People who have
an allergy to peanuts run the risk of serious or
life-threatening allergic reaction if they
consume these products. The select 7-ELEVEN
FRESH TO GO Cookies were sold at 7-ELEVEN
stores located throughout New York State. The
affected cookies are packed in a clear, plastic
film, two cookies per package, NET WT. 4 OZ.,
with Best By dates codes: Friday 0422,
Saturday 0423, and Sunday 0424 on the
front label.
No illnesses have been reported to date. The
recall was initiated after one of our suppliers
reported that three different cookie mixes may
contain undeclared peanuts. These potentially
contaminated cookie mixes were used in
production and distributed in packaging that
did not reveal the presence of peanuts. The
company and the ingredient supplier continue
their investigation to determine the cause of
the problem. Consumers who have purchased
the above Best By Date codes of the affected
cookies are urged to return them to the place
of purchase for a full refund. Consumers with
questions may contact the company at 1-800-
255-0711, Monday – Friday, 8am - 5pm, EDT.
April 27, 2016
Southeastern Grocers Issues Voluntary
Recall on Undeclared Peanuts in Bakery
Creme Cakes
Southeastern Grocers, the parent company
of BI-LO, Harveys and Winn-Dixie stores, is
voluntarily recalling its 32 ounce Bakery Crème
Cakes and 14 ounce Bakery Sliced Crème
Cakes, because the products may contain
undeclared peanuts. The 32 ounce Bakery
Crème Cakes and 14 ounce Bakery Sliced
Crème Cakes were distributed through all
BI-LO, Harveys and Winn-Dixie stores
throughout Alabama, Florida, Georgia,
Louisiana, Mississippi, North Carolina and
South Carolina in all counties.
BI-LO, Harveys and Winn-Dixie stores have
received no reports of illness from customers
associated with consumption of this product
and all affected product in the stores has been
discarded. The recall was initiated after
Southeastern Grocers was informed by
Benson's Bakery, the supplier of the bakery
cakes, that the bakery products potentially
contained peanuts in packaging that did not
reveal the presence of peanuts. Consumers
who have this product at home, and have a
peanut allergy, should discard the product
and return to the store for a full refund. To
receive the refund, customers may present
proof of purchase through a receipt or the
product-packaging label.Customers with
questions about the recalled products may
contact the Southeastern Grocers Customer
Call Center toll free at 866-946-6349, Mon. -
Fri., 8 a.m. - 6 p.m. EDT, and Sat., 8 a.m. - 4
p.m. EDT.
Bakery Express of Southern California Issues
Allergy Alert on Undeclared Peanut in
7-Eleven Fresh To Go Cookies
Bakery Express of Southern California of
Fullerton, CA is recalling 7-ELEVEN FRESH TO
GO brand cookies, because it may contain
undeclared peanuts. People who have an
allergy or severe sensitivity to peanuts run the
risk of serious or life-threatening allergic
reaction if they consume these products. The
7-ELEVEN FRESH TO GO cookies were
distributed and sold throughout Southern
California State including Los Angeles, San
Diego, and Bakersfield local 7-Eleven stores.
No illnesses have been reported to date. The
recall was initiated after one of our suppliers
reported that three different frozen cookies
RecallRegister | Aon Risk Solutions | May 2016	 10
April Recall Announcements, April 25 – 27, 2016
dough pucks may have contained undeclared
peanuts. These potentially contaminated
cookie pucks were used in production and
distributed in packaging that did not reveal
the presence of peanuts. The company and
the ingredient supplier continue their
investigation to determine the cause of the
problem. Consumers who have purchased the
above Best By date codes of the affected
cookies are urged to return them to the place
of purchase for a full refund. Consumers with
questions may contact the company at 1-714-
446-9470 Monday-Friday, 8am-5pm, PST.
April 28, 2016
7-Eleven Issues Allergy Alert on Undeclared
Peanut in Fresh Fully Baked Chocolate
Chunk, Sugar and Oatmeal Raisin Cookies
7-Eleven, Inc., Irving, Texas, is recalling fully
baked chocolate chunk, sugar and oatmeal
raisin cookies produced by CSM Bakery
Solutions frozen cookie pucks because they
may contain undeclared peanut. Fully baked
cookies prepared from frozen pucks were
distributed and sold prior to Friday, April 22 at
45 7-Eleven stores in Missouri, South Carolina
and Texas. Chocolate chunk, sugar and
oatmeal raisin cookies are sold fresh in a self-
serve bakery case or within a countertop self-
serve, acrylic case. There is no UPC code or
label attached to these cookies.
No illnesses have been reported to date.
7-Eleven was notified that these products may
contain undeclared peanut by its supplier and
has pulled all fully baked and frozen cookie
pucks provided by CSM Bakery Solutions from
our stores until the issue with our supplier is
resolved. Consumers who have purchased the
above are urged to discard. Consumers with
questions may contact the company at 1-800-
255-0711, Monday – Friday, 8 am – 5 pm EDT.
World's Choice Products, Inc. Issues Allergy
Alert on Undeclared Milk And Soy Lecithin
From Whey Protein in “Supreme Elixir”,
“Kids Juice” And “Xtreme Fiber Detox”
World's Choice Products, Inc., an Diego,
California, is recalling 32 fluid ounce “Supreme
Elixir” drink, 32 fluid ounce “Kid's Juice” drink,
1 pound and 8 ounce “Xtreme Fiber Detox”
because the products contain undeclared
whey protein, which contains the allergens of
milk and soy lecithin. The recall was initiated
after it was discovered by FDA that the whey
protein containing products were distributed
in packaging that did not reveal the presence
of whey protein.
No illnesses have been reported to date in
connection with this problem. The problem
was caused by a temporary breakdown in the
manufacturer's production and packaging
processes. Production of the product has been
suspended. Consumers who have “Supreme
Elixir”, “Kids Juice” and “Xtreme Fiber Detox”
are urged to return them to the place of
purchase for a full refund. Consumers with
questions may contact World's Choice
Products at 1-800-675-1845. We are open
Monday through Friday from 8 AM until 5:00
PM PST
April 28, 2016
Bakery Express of Central FL., Inc. Issues
Alleregy Alert on Undeclared Peanuts in
7-Eleven Fresh to Go Cookies
Bakery Express of Central FL., Inc of Orlando,
Florida is recalling select 7-ELEVEN FRESH TO
GO cookies, because they may contain
undeclared peanuts. People who have an
allergy or severe sensitivity to peanuts run the
risk of serious or life-threatening allergic
reaction if they consume these products. The
select 7-ELEVEN FRESH TO GO Cookies were
distributed to 7-Eleven convenience stores in
the state of Florida. The affected cookies are
packed in a clear package film, 2 cookies per
package, labeled “Fresh To Go” and have
“best buy” date codes Friday, 04/22/16,
Saturday, 04/23/16, Sunday, 04/24/16 on the
front label.
No illnesses have been reported to date.The
recall was initiated after one of our suppliers,
CSM Bakery Solutions, reported that three
different pre-bagged dry cookie mix bases
may contain undeclared peanuts. These
potentially contaminated cookie bases were
used in production and distributed in
packaging that did not reveal the presence of
peanuts. The company and the ingredient
supplier continue their investigation to
determine the cause of the problem.
Consumers who have purchased the above
“best buy” date codes of the affected cookies
are urged to return them to the place of
purchase for a full refund. Consumers with
questions may contact the company at 1-800-
255-0711 Monday – Friday, 8am – 5pm EDT
April 30, 2016
CSM Bakery Solutions Voluntary Recalls
8" Single Layer Red Velvet Cake Sold At
Safeway And 12” Decorated Chocolate Chip
Cookie Sold At Acme And Jewel Stores Due
To Undeclared Peanut Allergen
CSM Bakery Solutions, Atlanta, Georgia, is
voluntarily recalling the following products:
Safeway 8" Single Layer Red Velvet Cake,
ACME 12” Decorated Chocolate Chip Cookie,
and Jewel 12” Decorated Chocolate Chip
Cookie. People who have an allergy or severe
sensitivity to peanut run the risk of a serious or
life-threatening allergic reaction if they
consume these products. The 8” Single Layer
Red Velvet Cake was sold in Safeway stores in
Wyoming, Colorado, New Mexico (Farmington
and Aztec), South Dakota, and Nebraska. The
12” Decorated Chocolate Chip Cookie was
sold in Acme stores in Delaware, Maryland,
New Jersey, Pennsylvania, Connecticut, New
York and Jewel stores in Iowa, Illinois, and
Indiana.
No illnesses have been reported to date. The
recall was initiated after it was discovered by
CSM during post-production testing that flour
containing undeclared peanut as a result of
incidental contact was provided by a supplier
to CSM Bakery Solutions. The flour was used in
products distributed by CSM in packaging
that did not reveal the presence of peanut.
Consumers and wholesale customers who
have purchased the product are urged to
return it to the place of purchase for a full
refund. Consumers with questions may
contact CSM Bakery Solutions at
1-800-241-8526.
RecallRegister | Aon Risk Solutions | May 2016	 11
April Recall Announcements, April 27 – 30, 2016
Key Contacts
Aon Crisis Management
About Aon
Aon plc (NYSE:AON) is a leading global provider of risk management, insurance brokerage and
reinsurance brokerage, and human resources solutions and outsourcing services. Through its more
than 72,000 colleagues worldwide, Aon unites to empower results for clients in over 120 countries via
innovative risk and people solutions. For further information on our capabilities and to learn how we
empower results for clients, please visit: http://aon.mediaroom.com.
© Aon plc 2016. All rights reserved.
The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular
individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such
information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate
professional advice after a thorough examination of the particular situation.
Risk. Reinsurance. Human Resources.
Crisis Management
200 E. Randolph Drive,
Chicago, IL 60601
Bernie Steves
Managing Director
312.381.4945
bernie.steves@aon.com
Mary Duhig
312.381.4503
mary.duhig@aon.com
Jean McDermott-Lucey
212.441.1314
jean.mcdermott-lucey@aon.com
Marty Detmer
312.381.5114
marty.detmer4@aon.com
Joe Stottler
212.441.1795
Joseph.stottler1@aon.com
Caitlin Shea McGrath
212.441.1538
caitlin.mcgrath@aon.com
Going beyond traditional risk transfer solutions, our global network of product contamination and recall specialists offer a full range of
consultancy services, enabling clients to quantify their risk exposure and make informed decisions on the optimum balance between risk
retention, risk management and risk transfer.
Our team of specialist brokers, crisis consultants and in-house claims management combine threat assessment, impact analysis and crisis
management and response with individually structured insurance programs.
Our unique, consultative approach enables our clients to implement the most appropriate measures to meet their duty of care and better
protect their balance sheet, people, brand and reputation.

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May 2016 recall register

  • 1. RecallRegister May, 2016 A Message from Bernie Steves, Managing Director and Practice Leader, Crisis Management Welcome to the May Edition of Crisis Management’s RecallRegister, Aon’s monthly recall and product safety newsletter. This publication provides a review of the month’s recalls as reported by the U.S. Consumer Product Safety Commission (CPSC), the U.S Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), National Highway Traffic Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA). In addition to recall announcements, RecallRegister provides an update on the product recall and contamination insurance marketplace and environment. Each month, we highlight issues of importance including new markets and capacity, significant recall events and changes in legislation affecting the consumer products industry. In this Issue 01 Pilgrim's Pride Recalls 4.5 Million Pounds of Chicken Products 02 U.S. Department of Transportation Expands Takata Recall; 35-40 Millions Additional Airbags Through 2019 03 April Recall Announcements Pilgrim’s Pride Recalls 4.5 Million Pounds of Chicken Products After approximately 40,000 pounds of chicken nuggets were recalled earlier this month, Pilgrim’s Pride Corp. announced a recall of more than 4,500,000 pounds of fully cooked chicken products as a result of consumer complaints that the products contained extraneous material including metal and plastic. This nationwide recall includes more than 20 products that were produced between August 21, 2014 to March 1, 2016. The recall affects three brands: Gold Kist Farms, Pierce Chicken and Sweet Georgia Brand. Despite there being no confirmed reports of adverse reactions due to the consumption of these products, FSIS personnel identified the potentially affected product types and dates of production after investigating additional consumer complaints of foreign material contamination that the firm received. This investigation ultimately resulted in the most recent recall announcement of the 4,500,000 pounds of affected product. Learn more here. Risk. Reinsurance. Human Resources. Aon Risk Solutions Crisis Management Practice
  • 2. RecallRegister | Aon Risk Solutions | May 2016 2 U.S. Department of Transportation Expands Takata Recall; 35-40 Millions Additional Airbags Through 2019 During May 2016, the U.S. Department of Transportation expanded and accelerated the Takata air bag inflators recall to protect American drivers and passengers. This expansion was based on a five recall phase of prioritizing risk which was determined by the age of the inflators and exposure to high humidity and fluctuating high temperatures that accelerated the degradation of the chemical propellant. Ruptures of the Takata inflators have been tied to ten deaths and more than a hundred injuries in the United States. This recall decision follows the agency’s confirmation of the root cause behind the inflators’ propensity to rupture. Under the Amended Consent Order issued to Takata this week, the company is required to make a series of safety defect decisions that will support vehicle manufacturer recall campaigns of an additional estimated 30-40 million inflators. This expansion phase occurring, between May 2016 through December 2019, will add to the already 28.8 million air bag inflators previously recalled. Also, the expansions mean that all Takata ammonium nitrate-based propellant driver and passenger frontal air bag inflators without a chemical drying agent (also known as a desiccant) will be recalled. NHTSA will also consult with affected vehicle manufacturers before revising the Coordinated Remedy Order that governs the accelerated program to obtain and install replacement inflators. The Coordinated Remedy Program will continue to ensure that replacement inflators will be made available to highest-risk vehicles, first. The revised Coordinated Remedy Program, which will be announced later this summer, will detail the updated vehicle schedule with manufactures, supplies, parts, and repairs. Read more about the largest and most complex safety recall in U.S. history here. In the News
  • 3. April Recall Announcements The following recalls have been announced through the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Consumer Product Safety Commission (CPSC), National Highway Traffic Safety Administration (NHTSA) and the Canadian Food Inspection Agency (CFIA). These agencies are charged with protecting consumers from products that may pose injury to the public. This is only a representative list of recalls announced by these agencies during the month. A complete list of recalls, as well as actual press releases, is available at www.recalls.gov and http://www.inspection.gc.ca/english/toce.shtml April 1, 2016 Alimentos Congelados, S.A. Recalls Frozen Broccoli Cuts Because of Possible Health Risk Alimentos Congelados, S.A. (Pinula) is voluntarily recalling 1,800 cases of Frozen Broccoli Cuts because it has the potential to be contaminated with Listeria Monocytogenes. The Frozen Broccoli Cuts were distributed to stores in the following states: Indiana, Kentucky, Ohio, Tennessee, Virginia, West Virginia, Florida, Georgia, Alabama, South Carolina and North Carolina. The company has not received any complaints in relation to this product and is not aware of any illnesses associated with the product to date. The recall was the result of retail package of Frozen Broccoli Cuts being tested by the State of Ohio Department of Agriculture. The company has ceased distribution of Frozen Broccoli Cuts, and is fully cooperating with regulatory agencies. Consumers who purchased the Frozen Broccoli Cuts are urged not to consume this product and throw it away. Consumers requiring refund or with questions can contact the company at 1-800-888-4646 and ask for Consumer Affairs Monday thru Friday between 8:00AM and 5:00 PM EST April 4, 2016 WD Import and Export Inc. Issues an Alert on Dried Fish Due To Possible Health Risk WD Import and Export Inc., Brooklyn, New York, is recalling its bulk unlabeled cardboard boxes of Dried Yellow Fish because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life threatening illness or death. Botulism, a potential fatal form of food poisoning; people experiencing these problems should seek immediate medical attention. The product, Dried Yellow Fish was sold in bulk unlabeled and un-coded cardboard boxes and is a product of China. The product was sold in retail stores in New York City. Consumers are warned not to use the product even if it does not look or smell spoiled. No illnesses have been reported to date in connection with this problem. Consumers who have purchased Dried Fish are advised not to eat it, but should return it to the place of purchase. Consumers with questions may contact the company at 718-567-3339. The potential for contamination was noted after routine sampling by New York State Department of Agriculture and Markets Food Inspection and subsequent analysis of the product by Food Laboratory personnel confirming that the fish was not properly eviscerated prior to processing. Eleanor Rose Recalls Children’s Loungewear Due to Violation of Federal Flammability Standard Eleanor Rose, Natchez, Mississippi, has recalled children’s loungewear as it fails to meet federal flammability standards for children’s sleepwear, posing a risk of burn injuries to children. This recall affects about 5,900 unit. This recall involves two different styles of Eleanor Rose loungewear, including a girl’s gown and a boy or girl’s top and pants set. The loungewear was sold in sizes 12 months through size 12. “Eleanor Rose” is printed on a tag sewn into the neck of the garments and on the back outside of the pants. The style number is on a tag sewn into the side seam or inside the back of the pants. There are no incidents or injuries associated with this recall. Consumers should immediately take the recalled loungewear away from children and return it to Eleanor Rose for a merchandise credit towards the purchase of another Eleanor Rose product. April 5, 2016 Givenchy Recalls Men’s Silk T-Shirts Due to Violation of Federal Flammability Standard Givenchy, New York, New York, has recalled a men’s silk t-shirt, as it fails to meet the federal flammability standard for wearing apparel and pose a risk of burn injury to consumers. This recall affects about 60 units. This recall involves three styles of Givenchy-branded 100% silk T-shirts for men. The short-sleeve T-shirts are sheer and were sold in blue and black plaid, black and white stripes and black with an image of Jesus on the cross. They were sold in sizes XXS through L. The style number 16J7127135, 16J6218886 or 16J7205877 is printed on a tag sewn into the side seam. There have been no injuries or incidents reported. Consumers should immediately stop using the recalled T-shirts and return them to the place of purchase for a full refund. Givenchy is directly contacting consumers who bought the recalled T-shirts. Barneys New York, Givenchy Boutiques, Maxfield and Forward, Neiman Marcus and Nordstrom stores nationwide from February 2016 through March 2016 for between $685 and $1,350. April 6, 2016 Granna’s LLC Issues Allergy Alert On Undeclared Milk in French Toast Granna's LLC is voluntarily recalling packages of item number 808 French Toast that may contain an undeclared milk allergen. Product was distributed in Oklahoma through senior nutritional sites by home delivery. The affected product, #808 French Toast, was labeled without milk ingredient in the ingredient statement. The issue was discovered by a FDA investigator during an inspection of the recalling firm. Granna's RecallRegister | Aon Risk Solutions | May 2016 3 April Recall Announcements, April 1 – 6, 2016
  • 4. #808 French Toast with diced potatoes and mandarin oranges is a frozen dinner packaged in a black, three compartment heat sealed tray, with label located on top. This product is a food safety concern for people who are allergic to milk. There have been no illnesses as of April 5,2016 reported in connection with this product. Consumers with questions on the recall may contact Granna's LLC at 1-580-337- 6360. Consumers would have received the mislabeled product between April 2015 and April 2016. Affected packages should be discarded or returned to the place of purchase for a refund. Ivanka Trump Scarves Recalled by GBG Accessories Group Due to Violation of Federal Flammability Standard GBG Accessories Group (formerly LF Accessories Group, LLC), of New York has recalled women’s scarves as they do not meet the federal flammability standards for clothing textiles, posing a burn risk. This affects about 20,000 units. This recall involves two styles of Ivanka Trump-branded scarves, Beach Wave, in blue, coral and yellow; and Brushstroke Oblong, in blue, red, neutral and green. Both scarves are 76 inches long by 24 inches wide. Scarves are 100 percent rayon with a machine-rolled hem. A black label with “IVANKA TRUMP” embroidered in silver is sewn on the edge of the scarves. There have been no incidents / injuries reported. Consumers should immediately stop using the recalled scarves and return them to the place where purchased for a full refund. Consumers who purchased the scarves online will be contacted directly by online retailers with return instructions. Nipoamerican Recalls Mattresses Due to Violation of Federal Flammability Standard (Recall Alert) Nipoamerican, Inc., of Marlborough, Massachusetts, has issued a recall on all Niposul and NipoFlorida Elegance, Elegance Gold, and Evolution mattresses because they fail to meet the mandatory federal open flame standard for mattresses. This recall involves all models and sizes of Niposul and NipoFlorida Elegance, Elegance Gold, and Evolution mattresses. The Elegance and Evolution mattresses are white and the Elegance Gold mattresses are white with black sides. This recall affects about 325 units. No incidents or injuries have been reported. Niposul stores in Massachusetts and NipoFlorida stores in Florida from July 2014 through October 2015 for between $1,200 and $6,500. Consumers should contact Niposul or NipoFlorida for free mattress covers to bring the mattress into compliance with the federal standard and protect consumers from a fire. Assistance with installation is available upon request. April 7, 2016 Country Favor Issues Allergy Alert on Undeclared Peanuts in "Best Taste Keo Me Den Candy" Country Favor Inc., Maspeth, New York, is recalling its 120g packages of "Best Taste Keo Me Den Candy" food treats because they contain undeclared peanuts. The recalled "Best Taste Keo Me Den Candy" was distributed nationwide in retail stores. The product comes in a 120g clear and green plastic bag with an expiration date of 2017-12 stamped at the bottom. No Illnesses have been reported to date in connection with this problem. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel which revealed the presence of peanuts in packages of Best Taste Keo Me Den Candy that did not declare its presence. Consumers who have purchased 120g packages of "Best Taste Keo Me Den Candy" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 718-418-9400. Michel Et Augustin Inc. Issues Allergy Alert on Undeclared Hazelnuts in Petites Baguettes Butter Cookies Dark Chocolate Michel et Augustin Inc., Brooklyn, NY, is recalling approximately 900 packages of its Petites baguettes butter cookies Dark Chocolate, 6 packs only, because they may contain undeclared hazelnuts. Michel et Augustin Petites baguettes butter cookies Dark Chocolate were distributed to retail stores throughout New York City. No illnesses or complaints have been reported to date.The recall was initiated after the firm discovered packages that had visible pieces of nuts on top of the butter cookies. Subsequent investigation by the firm and foreign manufacturer revealed that a small quantity of packages of the milk chocolate and hazelnut recipe were incorrectly packed into Dark chocolate packages, and hazelnuts are not listed on the label. Consumers who have purchased Michel et Augustin Petites baguettes butter cookies Dark Chocolate, 6 packs, with Best before date 07 2016 and are allergic to hazelnuts should not consume this product. Consumers are urged to return the product to the place of purchase for a full refund. Consumers with questions should contact the company at 1-646-820-0935, Monday - Friday, 9 am – 6 pm, EDT. GolfBuddy GPS Bands Recalled by Deca International Due to Burn Hazarde Deca International Corp., dba GolfBuddy, of La Palma, California, has issued a recall because the band charging ports can produce an electrical charge to exposed skin, posing a burn hazard to consumers. This recall involves GolfBuddy BB5 golf GPS LED bands. The band is a wearable GPS unit that operates as a pedometer, distance monitor and watch and comes preloaded with golf course information. It is made of plastic with a stainless steel casing, has a LED display screen and a two-pronged connector at the end for closure. The display screen is flush with the top side of the band and has four buttons on the perimeter of the band. The model BB5 is on the back of the recalled unit below the charging port. Recalled units do not have a yellow round sticker on the front and on the packaging. The firm has received two reports of consumers being burned. This recall affects about 3,000 units. Consumers should immediately stop using the recalled golf wristbands and contact GolfBuddy for instructions on how to update the unit with the latest firmware, also available in the firm’s website. IKEA Recalls Children’s Bat Cape Costumes Due to Strangulation Hazard IKEA North America Services LLC, of Conshohocken, Pennsylvania, has recalled children’s bat cape costume due to the fabric hook and loop fastener at the neck of the bat cape can fail to detach readily during use, posing a strangulation hazard to children. This recall affects about 11,000 units. This recall involves IKEA children’s bat cape costumes. The capes are black with gray stripes, 100% polyester, measure 30 inches long by 57 inches wide and have a fabric hook and loop fastener closure at the neck. IKEA, LATTJO and numbers 60311650 and 18937 are printed on a white label sewn into the seam of the cape. RecallRegister | Aon Risk Solutions | May 2016 4 April Recall Announcements, April 6 – 7, 2016
  • 5. IKEA has received three reports outside of the United States of the fabric hook and loop fastener at the neck of the costume failing to detach readily and scratching children’s necks. Consumers should immediately take the recalled bat capes away from children and return the capes to any IKEA store for a full refund. IKEA stores nationwide and online at www.ikea-usa.com from November 2015 through February 2016 for about $13. April 8, 2016 Voluntary Recall of Fetch™ 2 Aspiration Catheter Boston Scientific, Marlborough, Massachusetts, has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death. There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax. April 10, 2016 Progressive Gourment Inc. Issues an Allergy Alert on Taste of Inspirations Edamame Rangoon Due to Possible Mislabeling and Undeclared Crustacean Shellfish Progressive Gourmet Inc., Wilmington, Massachusetts, is voluntarily recalling its frozen, 9 ounce packages of Taste of Inspirations Edamame Rangoon out of an abundance of caution because they have the potential to contain crustacean shellfish (crab). People who have an allergy to crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. The item is produced for Hannaford Supermarkets. The potentially impacted Edamame Rangoon were possibly sold to consumers at select Hannaford stores located in Maine, Massachusetts, New Hampshire, Vermont and New York. A consumer reported the mislabeling incident. The firm has initiated prompt corrective actions to prevent future mislabeling. No illnesses have been reported to date in connection with this product.Consumers who have purchased 9 ounce packages of the edamame rangoon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-224-7630 (9:00 am – 5:00 pm Monday through Friday EST). Reser's Fine Foods, Inc. Recalls Refrigerated Salads Because of Possible Health Risk Due to Onion Supplier Recall Reser's Fine Foods, Inc., Beaverton, Oregon is recalling nineteen refrigerated salad items due to notification from one of our ingredient suppliers that Listeria monocytogenes may be present in one lot of onions that was used in the manufacture of these salads. Listeria monocytogenes is an organism which can cause serious and sometime fatal infections in young children, frail or elderly people and individuals with weakened immune systems. Healthy people may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women. The retail product is sold in plastic containers and is marked with a Use By Date and the #10 at the end of the line of printing (see photo below). No illnesses have been reported to date. The recall was the result of a notification from one of our onion suppliers that the bacteria may be present in one lot of onions used in the manufacture of these refrigerated salads. No other items were manufactured using this lot of onions. Consumers are urged not to consume these products. Consumers who purchased these products may take them back to the store for a refund or discard them. April 11, 2016 Super Herbs Issues Voluntary Nationwide Recall Of SUPER HERBS Due To Presence Of Undeclared Sibutramine, Desmethylsibutramine and/or Phenolphthalein Super Herbs is voluntarily recalling all bottles of SUPER HERBS, light green and dark green capsules to the consumer level after FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. The product is used as a weight loss dietary supplement and is packaged in clear bottle with light green and dark green capsules. Super Herbs has not received any reports if adverse events related to this recall. The affected Super Herbs product includes all bottles which have been distributed nationwide to consumers via internet www. mysuperherbs.com. Super Herbs is notifying its customers by Email and is arranging for return. Consumers who are currently in possession of recalled Super Herbs light green and dark green capsules should stop using the product and contact Super Herbs. SUPER HERBS will be discontinued. EBB (U.S.) Inc. (English Bay Batter) Issues Voluntary Allergy Alert for PICs by Price Chopper Cinnamon Rolls with Cream Cheese Icing due to Incorrect Allergen Caution EBB (U.S.) Inc., Columbus, Ohio, is voluntarily recalling 97 cases of PICs by Price Chopper Cinnamon Rolls with Cream Cheese Icing (UPC 041735073389) because, although milk was listed in the ingredients list, it was mentioned in the wrong allergen caution. This voluntary recall has been issued by EBB (U.S.) Inc. out of an abundance of caution to protect consumers who might be at a risk from exposure to milk. To date, there have been no reports of illness in connection with use of this product. The RecallRegister | Aon Risk Solutions | May 2016 5 April Recall Announcements, April 7 – 11, 2016
  • 6. recall was initiated after it was discovered that the product label on the dairy- containing product listed milk as an ingredient but used the wrong allergen cautionary language. Consumers affected by this recall should immediately discard the product. Consumers with any questions should contact the company at 1-800-253- 6844 Monday through Friday, 9-4:30 Pacific Time. Back to Nature Issues Allergy Alert for Limited Number of Classic Crème Cookies Due to Undeclared Milk Back to Nature Foods, LLC, Naples, Florida, is voluntarily recalling two (2) lots of its Classic Crème cookies, 12 oz packages, because it may contain undeclared milk, not listed as an ingredient on the label. The affected product was distributed to retail stores nationwide. Packages are marked with a unit UPC #19898- 01103 and with best by dates of 10 SEP 16 and 16 SEP 16 labeled on top of the package. No other best by dates are affected. Consumers who have purchased the Back to Nature Classic Crème cookies with the UPC and dates noted, and have an allergy to milk, should destroy the product they have or are urged to return to the place of purchase for product replacement or refund. This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration. No other Back to Nature brand products are included in this recall. Consumers with questions may call Back to Nature’s Consumer Relations Center at 844- 275-5845. The center is open Monday through Friday from 9:00 a.m. to 5:00 p.m. Eastern. Consumers also may contact the center via e-mail by visiting the Contact Us page at http://www.backtonaturefoods.com for a replacement coupon. Dexcom, Inc., Issues Press Release to Supplement Previous Customer Notification Dexcom, Inc., San Diego, California, issues this press release to supplement its previous customer notification and remind its patients to periodically test the audible alarms and alerts on certain receivers manufactured by Dexcom to make sure that the audible alarms and alerts are functioning properly. The notification constituted a voluntary recall and applied to those Dexcom G4 Platinum Receivers, Dexcom G4 Platinum Pediatric Receivers, Dexcom G4 Platinum Professional Receivers, Dexcom G4 Platinum with Share Receivers, Dexcom G4 Platinum with Share Pediatric Receivers and the Dexcom G5 Mobile Receivers that are experiencing problems with audible alarms and alerts. There is no reason for patients to return receivers to Dexcom that are functioning properly. Dexcom issued the customer notification on February 23, 2016 via its website and certified mail to patients. The notification alerted customers of a potential issue affecting the audible alarms and alerts associated with the speaker component of certain receivers. Dexcom notified customers about this potential issue after receiving customer complaints about the receivers' speaker component. Specifically, the speaker failed to properly provide audible alerts and alarms in some or all instances. Customers who rely on audible alerts and alarms may not be notified of severe hypoglycemia or hyperglycemia if the speaker in their receiver does not function properly. The immediate health consequences of severe hypoglycemia include loss of consciousness, seizure, and in rare instances death. Whole Foods Market Recalls Mislabeled Asparagus, Pea and Ricotta Salad Due to Undeclared Allergen Whole Foods Market is recalling ten ounce packages of Asparagus, Pea and Ricotta salad because it was mislabeled and actually contained miniature Asparagus, Sun Dried Tomato and Swiss Frittatas. Due to the labeling error, an egg allergen was undeclared. The product was produced at the Whole Foods Market North Atlantic Kitchen in Everett, Massachusetts. No illnesses or reactions have been reported. The recalled product (UPC Code 0 36406 30344 5) contains frittatas and has a "sell by" date of April 14, 2016 and was sold on Sunday, April 10, 2016 at fourteen Whole Foods Market. Signage is posted in affected Whole Foods Market stores to notify customers of this recall. Consumers who have purchased this product from Whole Foods Market may return it to the store for a full refund. Consumers with questions should contact their local store or call 617-492-5500 between the hours of 9am and 5pm EST. April 12, 2016 Coleman Recalls Flashlights Due to Fire Hazard Coleman® CTAC Lithium-Ion Flashlights have been recalled due to the lithium-ion batteries can overheat, posing a fire hazard to consumers. This affects about 8,500 in the United States (in addition, about 500 were sold in Canada). This recall involves three models of Coleman® CTAC Lithium-Ion Flashlights. Models include CTAC20 (model 2000013874), CTAC40 (model 2000013873) and CTAC60 (model 2000013872). The flashlights are black, with “Coleman” printed in white along the handle and have the model number in white print on the upper portion of the handle next to the light. The flashlights are 6.5 inches long. The lithium-ion batteries inside the flashlights are red with the Coleman logo printed in white on the battery. Coleman has received two reports of the flashlight batteries overheating, catching fire and causing minor property damage. No injuries have been reported. Consumers should immediately stop using the recalled flashlights and contact Coleman for instructions on returning the flashlights for a full refund. April 13, 2016 Hospira Issues A Voluntary Recall For One Lot Of 50% Magnesium Sulfate Injection, USP Due To The Presence Of Particulate Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, to the hospital level due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop vial. A recall was previously executed for this lot on March 23, 2016 due to a confirmed high out of specification (OOS) result for pH. If the particulate is detected prior to dispensing or administration to a patient, patient harm is unlikely. If the delay of therapy is prolonged, there is the potential for serious medical consequences for mother and fetus requiring medical intervention. If the particulate is not observed prior to administration, it may result in localized swelling, redness, pain at the site of administration or veins, allergic reactions to RecallRegister | Aon Risk Solutions | May 2016 6 April Recall Announcements, April 11 – 13, 2016
  • 7. the foreign particle, microembolic effects as well as possible fetal harm. The likelihood of serious patient harm is considered low due to high-detectability of this non-conformance. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. This recall is being executed with the knowledge of the U.S. Food and Drug Administration. April 14, 2016 A&S Food Trading Inc. Issues Alert on Undeclared Sulfites in Gorgeous Memory Daylily A&S Food Trading Inc., Brooklyn, New York is recalling its 10.6 ounces (300 grams) packages of Gorgeous Memory Daylily because they contain undeclared sulfites. Consumers who have severe sensitivity to sulfites run risk of serious or life-threatening allergic reaction if they consume this product. The product comes in 10.6 ounces (300 grams) clear plastic bag. Gorgeous memory Daylily in 10.6 ounces (300 grams) packages was distributed in New York City area, and has reached consumers through retail stores. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspector and subsequent analysis by Food Laboratory personnel revealed the presence of sulfites in the 10.6 ounces (300 grams) package of Gorgeous memory Daylily, which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. No illnesses or allergic reaction involving this product have been reported to date. Consumers who have purchased 10.6 ounces (300 grams) packages of Gorgeous memory Daylily are urged to return them to the place of purchase for full refund. Consumers with questions may contact the company at 718-369-2648. Thomas Star Bakery of Ohio LLC Issues Voluntary Recall on Buns Bread Thomas Star Bakery of Ohio LLC, is voluntarily recalling Buns Bread, which contains undeclared allergens. The bread product contains milk and eggs, known allergens which are not declared on the label. The Buns Bread product was available for purchase between the dates of August 2015 and April 13, 2016. No other Thomas Star Bakery of Ohio products are involved in this recall. Ohio Department of Agriculture and the company have received no reports of adverse reaction due to consumption of this product. Anyone concerned about an injury or illness should contact a healthcare provider.The missing allergen information was discovered by the Ohio Department of Agriculture during an inspection of the recalling firm. Product involved in this recall can be brought to the place of purchase for a refund. Consumers with questions on the recall may contact Thomas Star Bakery of Ohio at (419) 214-0711. Sugarfina Issues Allergy Alert on Undeclared Peanuts in Milk Chocolate Malt Balls Sugarfina LLC, Ingelwood, California, is voluntarily recalling 742 units of its Sugerfina Milk Chocolate Malt Balls (UPC Code 840278113565, SKU K1159) because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life- threatening allergic reaction if they consume these products. The Sugarfina Milk Chocolate Malt Balls are packaged in 2" acrylic cubes. The product is pictured below. The UPC Code 840278113565 and SKU K1159 appears on the back panel of the label. No illnesses have been reported to date. The recall was initiated after it was discovered that some Sugarfina Peanut Butter Malt Balls had been mixed in with a batch of Sugarfina Milk Chocolate Malt Balls. Consumers who have purchased Sugarfina Milk Chocolate Malt Balls are urged to discard the product or return it to the place of purchase. Consumers with questions may contact the company at 855-784-2734 from 8AM to 5PM, PST, Monday-Friday. OLMA-XXI, Inc. Recalls Norven Herring in Oil Because of Possible Health Risk OLMA-XXI, Inc., Brooklyn, New York, is recalling Norven herring in oil, Lot 530611, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. No illnesses have been reported to date. The recall is the result of sampling and testing by the U.S. Food and Drug Administration (FDA) which revealed the presence of Listeria monocytogenes in the 17.6 oz. (500g) packages of NORVEN Herring in oil, Lot # 530611. The distribution of the product has been suspended while FDA and the company continue to investigate the source of the problem. Consumers who have purchased plastic containers of Norven herring in oil, Lot 530611, are urged not to consume this product and to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-718- 675-0706, Monday - Friday, 8 am - 6 pm, EDT. April 15, 2016 Back to Nature Expands Voluntary Recall for Limited Number of Classic Creme Cookies Due to Undeclared Milk Back to Nature Foods, LLC, Naples, Florida, is expanding its voluntary recall to include four (4) additional lots of its Classic Creme cookies, 12 oz packages, because they may contain undeclared milk, not listed as an ingredient on the label. Persons who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product. The affected product was distributed to retail stores nationwide. In addition to the previously announced affected packages that were marked with a unit UPC# 19898-01103 and with best by dates of 10 SEP 16 and 16 SEP 16 labeled on top of the package, Classic Creme cookies packages marked with a unit UPC# 19898-01103 and with best by dates of 13 AUG 16 and 08 OCT 16 and 21 OCT 16 and 22 OCT 16 labeled on top of the package were also affected. Consumers who have purchased the Back to Nature Classic Creme cookies with the UPC and dates noted, and have an allergy to milk, should destroy the product they have or are urged to return to the place of purchase for product replacement or refund. No other best by dates are affected. Consumers with questions may call Back to Nature’s Consumer Relations Center at 844-275-5845. The center is open Monday through Friday from 9:00 a.m. to 5:00 p.m. Eastern. No other Back to Nature brand products are included in this recall. This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration. RecallRegister | Aon Risk Solutions | May 2016 7 April Recall Announcements, April 13 – 15, 2016
  • 8. Mary's Home Canning Recalls Mary's Home Made Vegetable Soup Because of Possible Health Risk Mary's Home Canning, Lancaster, Pennsylvania, is recalling 516 jars of Mary's Homemade Vegetable Soup (Net Wt. 16 OZ) and 1,128 jars of Mary's Homemade Vegetable Soup (Net Wt. 32 OZ), because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. Botulism, a potentially fatal form of food poisoning; people experiencing these problems should seek immediate medical attention. No illnesses have been reported to date. The potential for contamination was noted after FDA testing found that the pH of the product was high and it did not receive an adequate process time or temperature. Anyone with a product fitting the above description should return the product to where it was purchased, if possible, or call Mary's Home Canning at 717-442-8349 for return instructions. Phone calls should be made during Eastern Standard Time. April 18, 2016 Midwest International Corp Issues Allergy Alert on Undeclared Milk in Hosdo Cake Midwest International Corp, Brooklyn, New York, is recalling HOSDO CAKE because it contains undeclared milk. Consumers who have allergies to milk run the risk of serious or life-threatening allergic reactions if they consume this product. In addition, this product was found to contain an unallowed, unidentified green/yellow fluorescent dye. The recalled HOSDO CAKE comes in a blue and white plastic wrapped, 7 ounce(200gram) package. All manufacturer and expiration date codes are affected. It was sold in New York City. No illnesses have been reported to date in connection with this product. Consumers who have purchased HOSDO CAKE should not consume it, but should return it to the place of purchase. Consumers with questions may contact the company at 646-388-3032. The recall was initiated after it was discovered through routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the presence of milk in packages of HOSDO CAKE which did not declare milk as an ingredient on the label. April 19, 2016 Exceptional Health Products Issues Allergy Alert On Undeclared Soy And Milk Allergens In Angel Wings™- Daily Multi 120 Capsules Exceptional Health Products, Tulsa, Oklahoma, is recalling Angel Wings™ - Daily Multi 120 Capsules because this product contains undeclared SOY and MILK allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product. The following product was distributed nationwide to consumers through mailorder. This voluntary recall has been initiated because this product contains undeclared SOY and MILK allergens. No illnesses have been reported to date. This was brought to our attention by the Food and Drug Administration that found inconsistencies with our supplier’s allergen statement on the Amino Acid ingredients used in this formulation. If you find the recalled lot numbers on the bottom of any bottle you have inventory you may return it to the address at the bottom for a full refund or replacement. If you have further distributed this product, please identify the recipients or your customers and notify them at once of this product recall. Nuvi Global Corporation Issues Allergy Alert on Undeclared Milk and Soy in StemVitae 30oz Liquid Multivitamin Nuvi Global Corporation, Rancho Cucamonga, California, is recalling StemVitae 30oz liquid multivitamin because it contains undeclared milk and soy lecithin. People who have an allergy or severe sensitivity to milk or soy run the risk of serious or life-threatening allergic reaction if they consume this product. The brand is Nuvi Global with a white and orange label that has the name StemVitae. The label contains an image of various fruits and vegetables. The lot number is 15556 and can be found printed in black ink underneath the bottle. No illnesses have been reported to date. The recall was initiated after it was discovered by the FDA that the ingredient whey protein was not declared on the label. The whey protein ingredient contains the allergens of milk and soy lecithin. Consumers who have purchased StemVitae liquid multivitamin are urged to return it to the company. Consumers with questions may contact the company at 844-740-6838 between the hours of 7:00am and 6:50pm PST Monday-Friday. April 20, 2016 Medtronic Announces Worldwide Voluntary Recall for Battery Pack In Covidien Oridion Labeled Capnostream™20 and Capnostream™ 20p Patient Monitors Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream™20 and Capnostream™20p Patient Monitors. This voluntary recall is being conducted due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. The scope of this recall includes battery pack model numbers 016400 and 010520. These packs were manufactured by a contract manufacturer between April 2014 and February 2016. Capnostream monitors are external (non-implantable) medical devices used to assess patients’ respiratory status and identify changes in breathing. The prescription device is operated by trained healthcare professionals in a clinical setting and in the home. Medtronic has received seven reports of thermal damage out of 9,817 battery packs impacted by this field action. Of these seven reports, one involved a fire resulting in smoke inhalation and minor burns. On April 15, 2016, Medtronic sent a letter to customers who have Capnostream battery packs affected by this voluntary recall. The Company also supplied a rework kit with full instructions for removal and proper disposal or recycling of the battery pack according to local policy. The eight cell, 14.3 volt, Lithium Ion battery pack is custom manufactured by third party contract manufacturers. The company recommends that customers use the Capnostream monitors on AC power (with the battery pack removed) until a replacement battery pack is available. The company has identified a manufacturing change conducted by the third party contract manufacturer as the probable root cause and is manufacturing new batteries that meet original specifications with a new contract manufacturer. The company will supply new batteries to affected customers RecallRegister | Aon Risk Solutions | May 2016 8 April Recall Announcements, April 15 – 20, 2016
  • 9. when available. No other Medtronic products are affected by this supplier of battery packs. Medtronic has contacted the FDA and other regulatory bodies to share information related to this issue. The company will continue working directly with government authorities and customers on this voluntary recall. April 21, 2016 Urgent Product Recall for Undeclared Soy and Milk Allergens MagZuma Nutrition , Tulsa, Oklahoma, is recalling effected lots of it’s Life’s Qik Fix™ and Zuma Supreme™ products because they contain undeclared soy and milk allergens. People who have an allergy or severe sensitivity to Soy or Milk allergens run the risk of serious or life-threatening allergic reaction if they consume this product. No illnesses have been reported to date and there are no other product concerns except for people that have Soy or Milk allergies. This voluntary recall has been initiated by Magzuma Nutrition because the Food and Drug Administration brought to our attention inconsistencies they found with our supplier’s allergen statement on the Amino Acid ingredients used in this formulation. The Zuma Supreme lot numbers began shipping nationwide on December 23, 2014 and the Life’s Qik Fix on February 8, 2016. If you find the recalled lot numbers on the bottom of any bottle you have in inventory you may return it to the address at the bottom for a full refund or replacement. If you have further distributed this product, please identify the recipients or your customers and notify them at once of this product recall. If you have any questions, call 888-306-8855 Monday thru Friday 8:00 AM to 5:00 PM CST. We are sorry for this inconvenience and appreciate your assistance. April 22, 2016 CSM Bakery Solutions Issues Allergy Alert on Undeclared Peanut in Chick-Fil-A Chocolate Chunk Cookies CSM Bakery Solutions, Atlanta, Georgia, is voluntarily recalling Chick-fil-A Chocolate Chunk Cookies because they may contain low levels of undeclared peanut. The recalled products were distributed through Chick-fil-A Restaurants. The recall was initiated after it was discovered by CSM during post- production testing that flour containing low-levels of undeclared peanut as a result of incidental contact was provided by a supplier to CSM Bakery Solutions. The flour was used in products distributed by CSM in packaging that did not reveal the presence of peanut. No illnesses have been reported to date. Consumers and wholesale customers who have purchased the product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact CSM Bakery Solutions at 1-800-241- 8526 extension 4, option 3. Calls can be made to this office during normal business hours (EST) during the week. April 23, 2016 CRF Frozen Foods Recalls Frozen Vegetables Due to Possible Health Risk CRF Frozen Foods, Pasco, Washington, is voluntarily recalling fifteen frozen vegetable items that have the potential to be contaminated with Listeria monocytogenes. The Listeria was discovered through routine testing by state health officials in Ohio. Listeria monocytogenes was found to be present in one lot of Individually Quick Frozen (IQF) organic petite green peas and one lot of IQF organic white sweet cut corn. No illnesses have been reported to date, but the company is recalling the products as a precaution. Consumers are urged not to consume these products. Consumers who purchased these products may take them back to the store where they purchased them for a refund or simply discard them. Consumers seeking information may call 1-844-483-3866 Monday through Friday, 8:00 am to 5:00 pm Pacific Standard Time. April 25, 2016 Fresenius Kabi Issues Voluntary Nationwide Recall of Sensorcaine® -MPF (bupivacaine HCl) Injection, USP due to the Presence of Particulate Matter Characterized as Glass Fresenius Kabi USA announced today it is voluntarily recalling a single lot of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial because due to visible particulate matter characterized as glass observed. Administration of a solution containing glass particulate matter by the epidural or retrobulbar (behind the eyeball) route may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. The recalled product is labeled with Product Code 470237 and Lot Number 6111504 and is supplied as 0.75% strength in a 30 mL single dose flint molded vial and packaged in units of 25. The product was shipped in the United States to wholesaler and distributor outlets between March 4, 2016 and March 21, 2016 and has an expiration date of September 2019. The NDC number for this product is 63323-472-37. To date, Fresenius Kabi has not received any reports of adverse events related to this recall. Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of all recalled product. If health care facilities have the affected lot, they are to immediately discontinue distributing, dispensing or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped the product involved in this recall and direct them to discontinue distributing, dispensing or using the affected lot and return the product to Fresenius Kabi. Consumers with questions regarding this recall can contact Fresenius Kabi at 1-800- 551-7176 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Old Home Kitchens Issues Allergy Alert and Voluntary Recall on Undeclared Peanuts in "Old Home Kitchens 14oz Sliced Creme Cakes" Old Home Kitchens, Bogart, Georgia, is voluntarily recalling “Old Home Kitchens 14oz. Sliced Lemon Crème Cake production code 16104 UPC 7121405521”, “Old Home Kitchens 14oz. Sliced Vanilla Crème Cake production code 16104 UPC 7121405520”, and “Old Home Kitchens 14oz. Sliced Strawberry Swirl Crème Cake with a production code of 16098 UPC 7121405522”, due to a potential presence of peanut allergen in a CSM Bakery Solutions supplied ingredient. People who have allergy or sensitivity to peanuts run the risk of serious or life threatening allergic reaction if they consume these products. The production codes can be found ink jet coded on the plastic clam shell packages. No Illnesses have been reported to date. The recall was initiated after Old Home Kitchens was informed by their ingredient supplier, CSM Bakery Solutions, an ingredient used in manufacturing the recalled products was potentially contaminated with an undeclared peanut allergen. The product packaging does not reveal the presence of peanuts. The RecallRegister | Aon Risk Solutions | May 2016 9 April Recall Announcements, April 20 – 25, 2016
  • 10. recall was initiated after Old Home Kitchens was informed by CSM Bakery Solutions that an ingredient supplied to Old Home Kitchens contained a peanut allergen. These Crème Cakes do not reveal the presence of peanuts. Old Home Kitchens has alerted the distributers of these retailers, which have removed this product from stores. The recall is being made with the knowledge of the U. S. Food and Drug Administration. Consumers who have purchased “Old Home Kitchens 14oz Sliced Crème Cake” with the codes noted above are urged to return it to their Retail Stores for product replacement or refund. No other “Old Home Kitchens” product is included in this recall. Krasnyi Oktyabr USA Inc. Recalls Vobla (Roach) Dry Eviscerated Salted Fish and Bream Dry Eviscerated Salted Fish Due to Possible Health Risk Krasnyi Oktyabr Inc., Brooklyn, New York, is recalling Vobla (Roach) Dry Eviscerated Salted Fish and Bream Dry Eviscerated Salted Fish because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life threatening illness or death. Consumers are warned not to use the products even if they do not look or smell spoiled. The products were imported from Russia and sold to retail stores in New York and California from February through April 2016. No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine sampling and inspection by the US Food and Drug Administration and subsequent analysis of the Bream fish by the FDA confirmed that the Bream fish was not properly eviscerated prior to processing. Consumers who have purchased Vobla Dry Eviscerated Salted Fish and Bream Dry Eviscerated Salted Fish are advised not to eat them, but should return them to the place of purchase. Consumers with questions may contact the company at 718-858-6720, Monday – Friday, 9 am – 4 pm EDT. April 26, 2016 Schaffner Distributing Pronutri LLC. Issues an Allergy Alert on Undeclared Soy Lecithin and Milk in Re-VITA-lize Schaffner Distributing Pronutri LLC. is recalling Re-VITA-lize LOT #15554, because it contains undeclared SOY Lecithin and MILK ingredient. People who have an allergy or severe sensitivity to SOY OR MILK ingredients may run the risk of serious or life-threatening allergic reaction if they consume these products. Re-VITA-Lize was distributed through retail stores and direct delivery to the following states, California, Washington, Oregon, Minnesota, Texas, and Iowa. The product is packaged in a 32oz white plastic bottle with the name Re-VITA-Lize Tropical Orange Flavor The lot number, lot #15554, can be found on the side of the bottle. No illnesses have been reported to date. The recall was initiated after it was discovered by FDA that the product contained undeclared whey protein which contains the allergens of milk and soy lecithin. Consumers who have purchased Re-VITA-Lize are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-866-688-7220 Monday–Friday 8am to 5pm PST. Glenn Wayne Wholesale Bakery Issues Allergy Alert on Undeclared Peanuts in Select 7-Eleven Fresh To Go Cookies Glenn Wayne Wholesale Bakery of Bohemia, New York, is recalling select 7-ELEVEN FRESH TO GO brand cookies because they may contain undeclared peanuts. People who have an allergy to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. The select 7-ELEVEN FRESH TO GO Cookies were sold at 7-ELEVEN stores located throughout New York State. The affected cookies are packed in a clear, plastic film, two cookies per package, NET WT. 4 OZ., with Best By dates codes: Friday 0422, Saturday 0423, and Sunday 0424 on the front label. No illnesses have been reported to date. The recall was initiated after one of our suppliers reported that three different cookie mixes may contain undeclared peanuts. These potentially contaminated cookie mixes were used in production and distributed in packaging that did not reveal the presence of peanuts. The company and the ingredient supplier continue their investigation to determine the cause of the problem. Consumers who have purchased the above Best By Date codes of the affected cookies are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800- 255-0711, Monday – Friday, 8am - 5pm, EDT. April 27, 2016 Southeastern Grocers Issues Voluntary Recall on Undeclared Peanuts in Bakery Creme Cakes Southeastern Grocers, the parent company of BI-LO, Harveys and Winn-Dixie stores, is voluntarily recalling its 32 ounce Bakery Crème Cakes and 14 ounce Bakery Sliced Crème Cakes, because the products may contain undeclared peanuts. The 32 ounce Bakery Crème Cakes and 14 ounce Bakery Sliced Crème Cakes were distributed through all BI-LO, Harveys and Winn-Dixie stores throughout Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina and South Carolina in all counties. BI-LO, Harveys and Winn-Dixie stores have received no reports of illness from customers associated with consumption of this product and all affected product in the stores has been discarded. The recall was initiated after Southeastern Grocers was informed by Benson's Bakery, the supplier of the bakery cakes, that the bakery products potentially contained peanuts in packaging that did not reveal the presence of peanuts. Consumers who have this product at home, and have a peanut allergy, should discard the product and return to the store for a full refund. To receive the refund, customers may present proof of purchase through a receipt or the product-packaging label.Customers with questions about the recalled products may contact the Southeastern Grocers Customer Call Center toll free at 866-946-6349, Mon. - Fri., 8 a.m. - 6 p.m. EDT, and Sat., 8 a.m. - 4 p.m. EDT. Bakery Express of Southern California Issues Allergy Alert on Undeclared Peanut in 7-Eleven Fresh To Go Cookies Bakery Express of Southern California of Fullerton, CA is recalling 7-ELEVEN FRESH TO GO brand cookies, because it may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. The 7-ELEVEN FRESH TO GO cookies were distributed and sold throughout Southern California State including Los Angeles, San Diego, and Bakersfield local 7-Eleven stores. No illnesses have been reported to date. The recall was initiated after one of our suppliers reported that three different frozen cookies RecallRegister | Aon Risk Solutions | May 2016 10 April Recall Announcements, April 25 – 27, 2016
  • 11. dough pucks may have contained undeclared peanuts. These potentially contaminated cookie pucks were used in production and distributed in packaging that did not reveal the presence of peanuts. The company and the ingredient supplier continue their investigation to determine the cause of the problem. Consumers who have purchased the above Best By date codes of the affected cookies are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-714- 446-9470 Monday-Friday, 8am-5pm, PST. April 28, 2016 7-Eleven Issues Allergy Alert on Undeclared Peanut in Fresh Fully Baked Chocolate Chunk, Sugar and Oatmeal Raisin Cookies 7-Eleven, Inc., Irving, Texas, is recalling fully baked chocolate chunk, sugar and oatmeal raisin cookies produced by CSM Bakery Solutions frozen cookie pucks because they may contain undeclared peanut. Fully baked cookies prepared from frozen pucks were distributed and sold prior to Friday, April 22 at 45 7-Eleven stores in Missouri, South Carolina and Texas. Chocolate chunk, sugar and oatmeal raisin cookies are sold fresh in a self- serve bakery case or within a countertop self- serve, acrylic case. There is no UPC code or label attached to these cookies. No illnesses have been reported to date. 7-Eleven was notified that these products may contain undeclared peanut by its supplier and has pulled all fully baked and frozen cookie pucks provided by CSM Bakery Solutions from our stores until the issue with our supplier is resolved. Consumers who have purchased the above are urged to discard. Consumers with questions may contact the company at 1-800- 255-0711, Monday – Friday, 8 am – 5 pm EDT. World's Choice Products, Inc. Issues Allergy Alert on Undeclared Milk And Soy Lecithin From Whey Protein in “Supreme Elixir”, “Kids Juice” And “Xtreme Fiber Detox” World's Choice Products, Inc., an Diego, California, is recalling 32 fluid ounce “Supreme Elixir” drink, 32 fluid ounce “Kid's Juice” drink, 1 pound and 8 ounce “Xtreme Fiber Detox” because the products contain undeclared whey protein, which contains the allergens of milk and soy lecithin. The recall was initiated after it was discovered by FDA that the whey protein containing products were distributed in packaging that did not reveal the presence of whey protein. No illnesses have been reported to date in connection with this problem. The problem was caused by a temporary breakdown in the manufacturer's production and packaging processes. Production of the product has been suspended. Consumers who have “Supreme Elixir”, “Kids Juice” and “Xtreme Fiber Detox” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact World's Choice Products at 1-800-675-1845. We are open Monday through Friday from 8 AM until 5:00 PM PST April 28, 2016 Bakery Express of Central FL., Inc. Issues Alleregy Alert on Undeclared Peanuts in 7-Eleven Fresh to Go Cookies Bakery Express of Central FL., Inc of Orlando, Florida is recalling select 7-ELEVEN FRESH TO GO cookies, because they may contain undeclared peanuts. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. The select 7-ELEVEN FRESH TO GO Cookies were distributed to 7-Eleven convenience stores in the state of Florida. The affected cookies are packed in a clear package film, 2 cookies per package, labeled “Fresh To Go” and have “best buy” date codes Friday, 04/22/16, Saturday, 04/23/16, Sunday, 04/24/16 on the front label. No illnesses have been reported to date.The recall was initiated after one of our suppliers, CSM Bakery Solutions, reported that three different pre-bagged dry cookie mix bases may contain undeclared peanuts. These potentially contaminated cookie bases were used in production and distributed in packaging that did not reveal the presence of peanuts. The company and the ingredient supplier continue their investigation to determine the cause of the problem. Consumers who have purchased the above “best buy” date codes of the affected cookies are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800- 255-0711 Monday – Friday, 8am – 5pm EDT April 30, 2016 CSM Bakery Solutions Voluntary Recalls 8" Single Layer Red Velvet Cake Sold At Safeway And 12” Decorated Chocolate Chip Cookie Sold At Acme And Jewel Stores Due To Undeclared Peanut Allergen CSM Bakery Solutions, Atlanta, Georgia, is voluntarily recalling the following products: Safeway 8" Single Layer Red Velvet Cake, ACME 12” Decorated Chocolate Chip Cookie, and Jewel 12” Decorated Chocolate Chip Cookie. People who have an allergy or severe sensitivity to peanut run the risk of a serious or life-threatening allergic reaction if they consume these products. The 8” Single Layer Red Velvet Cake was sold in Safeway stores in Wyoming, Colorado, New Mexico (Farmington and Aztec), South Dakota, and Nebraska. The 12” Decorated Chocolate Chip Cookie was sold in Acme stores in Delaware, Maryland, New Jersey, Pennsylvania, Connecticut, New York and Jewel stores in Iowa, Illinois, and Indiana. No illnesses have been reported to date. The recall was initiated after it was discovered by CSM during post-production testing that flour containing undeclared peanut as a result of incidental contact was provided by a supplier to CSM Bakery Solutions. The flour was used in products distributed by CSM in packaging that did not reveal the presence of peanut. Consumers and wholesale customers who have purchased the product are urged to return it to the place of purchase for a full refund. Consumers with questions may contact CSM Bakery Solutions at 1-800-241-8526. RecallRegister | Aon Risk Solutions | May 2016 11 April Recall Announcements, April 27 – 30, 2016
  • 12. Key Contacts Aon Crisis Management About Aon Aon plc (NYSE:AON) is a leading global provider of risk management, insurance brokerage and reinsurance brokerage, and human resources solutions and outsourcing services. Through its more than 72,000 colleagues worldwide, Aon unites to empower results for clients in over 120 countries via innovative risk and people solutions. For further information on our capabilities and to learn how we empower results for clients, please visit: http://aon.mediaroom.com. © Aon plc 2016. All rights reserved. The information contained herein and the statements expressed are of a general nature and are not intended to address the circumstances of any particular individual or entity. Although we endeavor to provide accurate and timely information and use sources we consider reliable, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. Risk. Reinsurance. Human Resources. Crisis Management 200 E. Randolph Drive, Chicago, IL 60601 Bernie Steves Managing Director 312.381.4945 bernie.steves@aon.com Mary Duhig 312.381.4503 mary.duhig@aon.com Jean McDermott-Lucey 212.441.1314 jean.mcdermott-lucey@aon.com Marty Detmer 312.381.5114 marty.detmer4@aon.com Joe Stottler 212.441.1795 Joseph.stottler1@aon.com Caitlin Shea McGrath 212.441.1538 caitlin.mcgrath@aon.com Going beyond traditional risk transfer solutions, our global network of product contamination and recall specialists offer a full range of consultancy services, enabling clients to quantify their risk exposure and make informed decisions on the optimum balance between risk retention, risk management and risk transfer. Our team of specialist brokers, crisis consultants and in-house claims management combine threat assessment, impact analysis and crisis management and response with individually structured insurance programs. Our unique, consultative approach enables our clients to implement the most appropriate measures to meet their duty of care and better protect their balance sheet, people, brand and reputation.