The document discusses product recalls, providing statistics on medical device and drug recalls from 2008 to October of an unspecified year. It notes that the medical field faces significant liability exposure if a recall notice is missed due to the potential safety impacts. Current challenges with recalls include a lack of visibility and control across extended supply chains, disparate electronic record systems, and non-scalable tracking methods. A distributed, secure system is needed to efficiently execute and track recalls across organizations.

1. Product Recalls: Did you know? 2008 (Jan – Oct) recalls in medical field* 9M toys recalled in last year alone , “Slim chance of getting back even 10%”** Other examples: Sony replaces 9M laptop batteries, Nokia offers to replace 46M cell phone batteries, Bad flu shots (Kaiser) impact 8-10K people in Northwest (10/23) etc. Data obtained from www.recalls.org; The medical field is being highlighted as products are regulated and highly controlled, and the impact of a recall of any of these items typically has significant impact on safety - huge liability exposure for the institution that misses a recall notice. They require very timely response in that is common for only one "batch" of an item to have a recall problem. ** Kids in Danger (non profit for improved safety standards for kids products) Category # of Recall Events # of units Recalled Medical Devices 638 97,102,171 Drugs 111 245,481,569 Biological 1165 1,961,127

2. Current Challenges Lack of visibility & control within and across extended enterprise Electronic record and actual inventory / location typically out of sync within 4 walls Participating parties usually have disparate electronic systems in place Barcodes are a non scalable way to create an on-demand search and locate system Multiple parties across firewalls need to be involved to execute a successful recall process in a non-disruptive manner Data is federated, business process is distributed Distributed, secure system required to execute and track a recall business process across the extended enterprise

3. Overall Impact Impact on company’s bottom-line Huge liability exposure for manufacturers and organizations upstream that miss a recall notice Enormous expenses occurred to locate and remove tainted products Impact on people’s lives Damper on consumer benefits from a globalized supply chain in a ‘flat’ extended enterprise world Loss of a company’s name in the marketplace Plummeting of public confidence Continued presence of dangerous non-recalled products in supply chain