Recall Z-0019-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit SG
| Date | Oct 15, 2003 (initiated Aug 18, 2003) |
| Status | Terminated |
| Reason | The heart valve procurement exceeded the warm ischemic time criteria. |
| Root cause | Other |
| Action | The physician was notified by letter on 8/18/2002. The tissue was reported implanted on 4/08/2003. |
| Quantity | 1 unit |
| Distribution | 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.