Recall Z-0548-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Pulmonary Valve and Conduit
| Date | Feb 25, 2004 (initiated Dec 10, 2003) |
| Status | Terminated |
| Reason | As part of this ongoing retrospective review, CryoLife has identified a donor who does not meet current guidelines regarding serodilution of plasma because of the amount of transfused/infused fluids administered. |
| Root cause | Other |
| Action | The consignee was notified by letter on 12/10/2003. CryoLife received confirmation of receipt of the notification from the physician who reported the tissue was implanted on 04/17/1997. |
| Quantity | 1 unit |
| Distribution | The allograft was shipped to one physician in TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.