Recall Z-0580-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Mar 10, 2005 (initiated Dec 17, 2004) |
| Status | Terminated |
| Reason | Records noted that the infant donor's mother had tested positive for Hepatitis B. |
| Root cause | Other |
| Action | Physicians were notified by letter on 12/17/2004. |
| Quantity | 1 tissue |
| Distribution | CA, FL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.