Recall Z-0167-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Pulmonary Valve & Conduct
| Date | Nov 27, 2003 (initiated Nov 4, 2003) |
| Status | Terminated |
| Reason | CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site. |
| Root cause | Other |
| Action | Consignee was notified by letter on 11/4/2003. The tissue was reported implanted on 10/14/2003. The letter was intended to provide the hospital with a basis to determine if any additional patient surveillance or intervention is necessary. A self addressed, stamped postcard was enclosed to verify receipt of notification. |
| Quantity | One unit |
| Distribution | The tissue was shipped to one hospital in MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.