Recall Z-0685-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Aortic Valve & Conduit
| Date | Apr 6, 2005 (initiated Dec 17, 2004) |
| Status | Terminated |
| Reason | During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation. |
| Root cause | Other |
| Action | Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005. |
| Quantity | 1 tissue |
| Distribution | CA, NJ, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.