Recall Z-1188-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Heart Valve
| Date | Aug 29, 2003 (initiated Apr 1, 2003) |
| Status | Terminated |
| Reason | CryoLife initiated a retrospective review per FDA request, to insure that current regulatory guidelines for donor blood testing have been met for certain donors. |
| Root cause | Other |
| Action | Consignees were notified by letter sent on various dates starting April, 2003 and were advised to provide the disposition of the tissue to CryoLife. |
| Quantity | 325 units |
| Distribution | Tissues were distributed to hospitals and physicians located nationwide and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.