Recall Z-0988-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft, Aortic Valve & Conduit
| Date | Jul 10, 2003 (initiated May 5, 2003) |
| Status | Terminated |
| Reason | Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy. |
| Root cause | Other |
| Action | The hospital was notified by letter on 5/05/2003. |
| Quantity | 1 unit |
| Distribution | Unit was distributed to one hospital in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.