Recall Z-0719-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft, Heart valve.
| Date | Apr 10, 2003 (initiated Feb 24, 2003) |
| Status | Terminated |
| Reason | Pre-processing cultures detected certain microorganisms in donor tissue. |
| Root cause | Other |
| Action | Consignees were first notified by telephone on 2/24/2003 with follow up letter on March 6, 2003 and were advised, if the tissue had not yet been implanted, to remove tissue from implantable inventory and place it into quarantine. CryoLife will provide specific instructions for returning the tissue. A stamped, self-addressed postcard was provided to confirm receipt of the notice and to provide information regarding the disposition of the tissue. |
| Quantity | 2 individual heart valve allografts. |
| Distribution | Heart allografts were distributed to two hospitals in OH and Quebec, Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.