CryoLife, Inc. - CryoValve SG Pulmonary Human Heart Valve - Class 2 Recall

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 135¿C. CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts