Recall Z-0528-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
Synergraft CryoValve, Aortic Valve & Conduit SG
| Date | Jul 20, 2004 (initiated Jan 16, 2004) |
| Status | Terminated |
| Reason | Microorganisms were detected in associated tissue. |
| Root cause | Other |
| Action | Consignees were notified by letter on 1/16/2004. |
| Quantity | 1 unit |
| Distribution | CA, MI,OK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.