Recall Z-0859-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
Aortic Valve & Conduit
| Date | Jun 1, 2005 (initiated May 17, 2005) |
| Status | Terminated |
| Reason | Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time. |
| Root cause | Other |
| Action | Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed. |
| Quantity | 1 unit |
| Distribution | IL, MT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.