Recall Z-0776-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Aortic Valve & Conduit
| Date | Jul 20, 2004 (initiated Feb 20, 2004) |
| Status | Terminated |
| Reason | Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila. |
| Root cause | Other |
| Action | Consignee was notified first by telephone on 02/20/2004, then with follow up letter on 04/02/2004. |
| Quantity | 1 unit |
| Distribution | This tissue was distributed to one physician in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.