Recall Z-1593-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve and Conduit
| Date | Oct 1, 2005 (initiated Jan 26, 2004) |
| Status | Terminated |
| Reason | Mislabeling; An allograft labeled as an aortic valve & conduit, actually contained a pulmonary valve and conduit. |
| Root cause | Other |
| Action | Consignee was notified by letter on 01/26/2004. The tissue was returned to CryoLife and destroyed. |
| Quantity | 1 tissue |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.