Recall Z-0672-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft, Heart valve
| Date | Mar 21, 2003 (initiated Feb 4, 2003) |
| Status | Terminated |
| Reason | Microorganisms were detected in distributed allografts. |
| Root cause | Other |
| Action | CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a respons |
| Quantity | 2 units |
| Distribution | The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.