Recall Z-1589-05 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Sep 28, 2005 (initiated Apr 19, 2004) |
| Status | Terminated |
| Reason | This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection. |
| Root cause | Other |
| Action | Consignees were notified by telephone and letter on 04/19/2004. |
| Quantity | 1 tissue |
| Distribution | MO, TX and Sidney Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.