Recall Z-0298-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Dec 8, 2004 (initiated Jul 28, 2004) |
| Status | Terminated |
| Reason | CryoLife received information stating that the tissue donation was deferred due to possible Hepaititis C suspected by the MD. |
| Root cause | Other |
| Action | Consignee was notified verbally on 07/28/2004. The Allograft was retrieved and discarded. |
| Quantity | 1 tissue |
| Distribution | MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.