Recall Z-0673-03 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve Allograft, heart valve
| Date | Mar 21, 2003 (initiated Feb 18, 2003) |
| Status | Terminated |
| Reason | Microorganisms were detected in distributed donor tissue. |
| Root cause | Other |
| Action | Medical facilities were contacted by CryoLife Technical Representatives via letter on/about 2/20/2003 to alert the facility of the removal and to determine the disposition of the allografts. Firms were advised, if the tissue has not been implanted, not to implant or distribute the tissue and to place it into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department-Field Assurance, and a representative would issue a Return Materials Authorization number and will provide specific instructions for returning the tissue. There is a stamped, self addressed postcard attached t |
| Quantity | There were six (6) individual heart valve allografts. |
| Distribution | Tissue products were distributed to Medical facilities located in CA, MD, ME and SD. There were no foreign or government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.