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 crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
- Company
- Cryolife Inc
- Recall Initiated
- November 10, 2020
- Terminated
- October 26, 2021
- Recall Number
- Z-0652-2021
- Quantity
- 3 units
- Firm Location
- Kennesaw, GA
Reason for Recall
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.
Distribution
Distributed nationwide to GA, AZ, TX, MO, and OK.
Lot / Code Info
Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447
Root Cause
Material/Component Contamination
Action Taken
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 the affected product. If the product has been implanted and the consignee has questions or requires clarification, the consignee is to contact Dr. Gregory Ray, CryloLife Medical Director at 800-438-8285.