Recall Z-0939-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Pulmonary Valve & Conduit.
| Date | Jun 17, 2003 (initiated May 23, 2003) |
| Status | Terminated |
| Reason | Microorganisms detected in associated allografts. |
| Root cause | Other |
| Action | The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003. |
| Quantity | 2 individual heart valve allografts. |
| Distribution | The tissues were distributed to one medical facility in CT and to one physician in MT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.