Recall Z-0169-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve and Conduit - SG
| Date | Nov 3, 2004 (initiated May 6, 2004) |
| Status | Terminated |
| Reason | CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about May 6, 2004. |
| Quantity | 6 units |
| Distribution | Nationwide, Austria, Canada, Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.