Recall Z-0480-06 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Feb 4, 2006 (initiated Jan 27, 2006) |
| Status | Terminated |
| Reason | Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection. |
| Root cause | Other |
| Action | Physicians were notified by letter on 1/27/2006. |
| Quantity | 1 unit |
| Distribution | NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.