Recall Z-0479-06 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit SG
| Date | Feb 4, 2006 (initiated May 6, 2004) |
| Status | Terminated |
| Reason | During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts. |
| Root cause | Other |
| Action | Consignees were notified by letter dated May 6, May 11, or May 12, 2004. |
| Quantity | 3 units |
| Distribution | FL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.