Recall Z-1297-03 ยท NJK Valve, Pulmonary
Cryolife Inc
CryoValve, Pulmonary Valve & Conduit
| Date | Oct 15, 2003 (initiated Sep 10, 2003) |
| Status | Terminated |
| Reason | Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results. |
| Root cause | Other |
| Action | Consignees were notified by letter on 09/10/2003 and 09/12/2003. |
| Quantity | 1 unit |
| Distribution | The tissues were distributed to one hospital in CA and one physician in MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.