Recall Z-2271-2018 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
CryoLife, Inc.
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
| Date | May 14, 2018 |
| Status | Terminated |
| Reason | Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine. |
| Root cause | Under Investigation by firm |
| Action | The firm notified the consignees by letter on 05/14/2018. |
| Quantity | 1 unit |
| Distribution | AR, OH |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) Cryolife, Inc., May 25, 2010 |