Recall Z-1484-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Conduit and Pulmonary Valve and Conduit
| Date | Sep 23, 2004 (initiated Apr 12, 2004) |
| Status | Terminated |
| Reason | CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor. |
| Root cause | Other |
| Action | Consignee was notified via telephone on 4/12/2004. The tissue was returned and destroyed. |
| Quantity | 1 tissue |
| Distribution | NM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.