Recall Z-0675-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft heart valve
| Date | Mar 21, 2003 (initiated Jan 23, 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. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A 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 | The unit was distributed to one Hospital facility in IN. 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.