Enforcement Report - Week of December 12, 2012
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Product Detail
| Product Description | Tendon, human tissue for transplantation, |
|---|---|
| Recall Number | B-0353-13 |
| Classification | Class II |
| Code Info | Serial numbers: 1012784001, 1012784002, 1012784003, 1012784004, 1012784005, 1012784006, 1012784007, 1012784008, 1012784009, 1012784010 |
| Product Distributed Qty | 10 tissues |
| Reason For Recall | Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. |
Event Detail
| Event Id | 62610 |
|---|---|
| Product Type | Biologics |
| Status | Completed |
| Recalling Firm | LifeNet Health |
| City | Virginia Beach |
| State | VA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-01 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | The tissues were shipped nationwide and to Canada and Korea. |
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