Recall Z-0866-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft, Heart valve
| Date | May 22, 2003 (initiated Apr 30, 2003) |
| Status | Terminated |
| Reason | Microorganisms were detected in associated allografts. |
| Root cause | Other |
| Action | Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft. |
| Quantity | 8 units |
| Distribution | The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.