Recall Z-0026-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Oct 20, 2004 (initiated Jul 15, 2004) |
| Status | Terminated |
| Reason | A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus. |
| Root cause | Other |
| Action | The physician was notified by letter on 07/15/2004. |
| Quantity | 1 tissue |
| Distribution | The tissue was shipped 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.