Recall Z-0855-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Conduit and Pulmonary Valve and Conduit
| Date | Jul 20, 2004 (initiated Feb 25, 2004) |
| Status | Terminated |
| Reason | A retrospective review of donor files conducted by CryoLife revealed an expired solution had been used during processing of the associated tissues. |
| Root cause | Other |
| Action | Consignees were notified by letter on 03/02/2004. |
| Quantity | 1 unit |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.