Enforcement Report - Week of December 12, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| Decellularized Dermis (Skin, human tissue for transplantation), product codes AFLEX100, AFLEX101, DCELL102, DCELL200, and DCELL251 | Serial numbers: 1012784D190, 1012784D191, 1012784D192, 1012784D193, 1012784D194, 1012784D195, 1012784D196, 1012784D197, 1012784D198, 1012784D199, 1012784D200, 1012784D201, 1012784D202, 1012784D212, 1012784D213, 1012784D214, 1012784D218 | Class II | Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. | 17 tissues | B-0350-13 |
| Fascia, human tissue for transplantation, product code FL M | Serial number: 1012784045 | Class II | Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. | 1 tissue | B-0351-13 |
| Bone, human tissue for transplantation, product code VG2C-T57, FIB4013, CAN90 410BP, CAN15 410BP, CAN90 14BP and CAN15 14BP. | 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 | Class II | Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. | 42 tissues | B-0352-13 |
| Tendon, human tissue for transplantation, | Serial numbers: 1012784001, 1012784002, 1012784003, 1012784004, 1012784005, 1012784006, 1012784007, 1012784008, 1012784009, 1012784010 | Class II | Human tissue allografts, recovered from a donor with a medical history that indicated risk factors for communicable disease agents and diseases, were distributed. | 10 tissues | B-0353-13 |
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