Recall Z-0652-2021 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
CryoLife, Inc.
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystal
| Date | Nov 10, 2020 |
| Status | Terminated |
| Reason | On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall. |
| Root cause | Material/Component Contamination |
| Action | A Recall notification letter titled "Urgent - Voluntary Human Tissue Recall" was sent to consignees via email or hand delivered by firm representatives. On 11-Nov-2020, 4 letters were delivered to consignees. On 12-Nov-2020, 2 letters were delivered to consignees. The letter instructs the consignee to complete and return the enclosed postcard affirming that they received the notification. The affected product should be quarantined and returned to CryoLife immediately, if it has not been implanted. CryoLife Field Representatives were to provide information necessary to arrange for the return of |
| Quantity | 3 units |
| Distribution | Distributed nationwide to GA, AZ, TX, MO, and OK. |
| 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 |