Recall Z-0669-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve and Conduit
| Date | Apr 6, 2005 (initiated Jan 12, 2005) |
| Status | Terminated |
| Reason | During a retrospective review CryoLife's Medical Director identified pre-processing and incoming bioburden cultures of the heart tissue, which detected Staphylococcus aureas. |
| Root cause | Other |
| Action | Consignee was notified by letter on 01/12/2005. |
| Quantity | 1 tissue |
| Distribution | KS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.