Recall Z-0842-2007 ยท MIE Heart-Valve, Allograft
CryoLife, Inc.
Aortic Valve & Conduit
| Date | Jun 7, 2007 (initiated Apr 17, 2007) |
| Status | Terminated |
| Reason | Donor tissue was released prior to information received regarding a pericardial effusion. |
| Root cause | Other |
| Action | Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife |
| Quantity | 1 tissue |
| Distribution | AZ, CO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.