Recall Z-1134-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Aortic Valve
| Date | Jul 22, 2004 (initiated Jul 1, 2004) |
| Status | Terminated |
| Reason | The sterilization cycle for the instruments used during the procurement of the tissue from the donor had expired. |
| Root cause | Other |
| Action | The physicians were notified by letter on 07/01/2004. Both tissues were reported implanted. |
| Quantity | 1 unit |
| Distribution | CA, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.