Recall Z-0746-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Aortic Valve and Conduit
| Date | Jul 20, 2004 (initiated Feb 18, 2004) |
| Status | Terminated |
| Reason | CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995. |
| Root cause | Other |
| Action | Consignees were notified by telephone on 02/18/2004. |
| Quantity | 1 unit |
| Distribution | DC, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.