Recall Z-0814-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve and Conduit
| Date | Jul 20, 2004 (initiated Jan 30, 2004) |
| Status | Terminated |
| Reason | CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347. |
| Root cause | Other |
| Action | The consignee was contacted by telephone by the CryoLife Medical Director on 01/30/2004. |
| Quantity | 1 unit |
| Distribution | The tissue was distributed to one physician in IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.