Recall Z-0065-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Heart Valve
| Date | Oct 24, 2003 (initiated Sep 25, 2003) |
| Status | Terminated |
| Reason | Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a systemic infection. |
| Root cause | Other |
| Action | The implanting physician was notified by letter on 9/25/2003. The tissue was reported implanted therefore notification was intended to provide the physician with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed stamped postcard was enclosed to affirm receipt of notification. |
| Quantity | 1 unit |
| Distribution | The tissue was distributed to one physician in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.