Enforcement Report - Week of December 12, 2012
-
Back to Previous Page
Product Detail
| Product Description | Bone, human tissue for transplantation, product code VG2C-T57, FIB4013, CAN90 410BP, CAN15 410BP, CAN90 14BP and CAN15 14BP. |
|---|---|
| Recall Number | B-0352-13 |
| Classification | Class II |
| Code Info | Serial numbers: 1012784011, 1012784012, 1012784013, 1012784014, 1012784015, 1012784016, 1012784017, 1012784018, 1012784019, 1012784020, 1012784021, 1012784022, 1012784023, 1012784024, 1012784025, 1012784026, 1012784027, 1012784028, 1012784029, 1012784030, 1012784031, 1012784032, 1012784033, 1012784034, 1012784035, 1012784036, 1012784037, 1012784038, 1012784039, 1012784040, 1012784041, 1012784042, 1012784043, 1012784044, 1012784047, 1012784048, 1012784049, 1012784050, 1012784051, 1012784052, 1012784053, 1012784054 |
| Product Distributed Qty | 42 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. |
-
