Recall Z-1524-2008 ยท MIE Heart-Valve, Allograft
CryoLife, Inc.
CryoValve, Pulmonary Valve & Conduit
| Date | Sep 1, 2008 (initiated Mar 26, 2008) |
| Status | Terminated |
| Reason | Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed. |
| Root cause | Material/Component Contamination |
| Action | Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction. |
| Quantity | 1 tissue |
| Distribution | Hospitals in DE, TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033484 | HUMAN HEART VALVE, CRYOVALVE SG Cryolife, Inc., Feb 7, 2008 |