Recall Z-0676-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft heart valve
| Date | Mar 21, 2003 (initiated Jan 30, 2003) |
| Status | Terminated |
| Reason | An allograft associated with this donor has been linked to an alleged infection. |
| Root cause | Other |
| Action | A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. The allograft SID 72552025 (V00) was located in storage at the SUNY University Hospital, Syracuse, NY. The CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction. |
| Quantity | 1 unit |
| Distribution | One unit was distributed to one Hospital facility in NY. There are no foreign or government accounts involved. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.