Recall Z-1038-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Synegraft Pulmonary Valve & Conduit
| Date | Jul 22, 2003 (initiated Jul 10, 2003) |
| Status | Terminated |
| Reason | Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed. |
| Root cause | Other |
| Action | The physician was notified by letter on 7/10/2003. |
| Quantity | 1 tissue |
| Distribution | The 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.