Recall Z-0861-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft, Pulmonary Heart valve & Conduit.
| Date | May 22, 2003 (initiated May 5, 2003) |
| Status | Terminated |
| Reason | Microorganisms were detected in associated allografts after initial release of donor. |
| Root cause | Other |
| Action | The implanting physician was notified via letter on May 5, 2003. Allograft was reported implanted 1/17/2003. |
| Quantity | 1 unit |
| Distribution | Allograft was distributed to and implanted by one physician in California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.