Recall Z-0516-04 ยท MIE Heart-Valve, Allograft
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Feb 10, 2004 (initiated Nov 10, 2003) |
| Status | Terminated |
| Reason | The firm received additional information from the procurement agency indicating that Yeast was detected in the musculoskeletal procurement cultures for the hemi pelvis. |
| Root cause | Other |
| Action | Consignee was first notified by telephone on 11/10/2003, with a follow up letter sent 12/10/2003. If the tissue had been implanted the consignee was advised to forward that information to CryoLife''s Regulatory Department-Field Assurance. If the tissue had not been implanted the consignee was advised not to implant or further distribute the tissue. They were instructed to remove the tissue from the implantable inventory and to place it into quarantine pending return to CryoLife. A self addressed, stamped postcard was included to affirm receipt of notification and to acknowledge that the tissu |
| Quantity | 1 unit |
| Distribution | The tissue was issued to one hospital in CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.