CryoLife, Inc. recalls CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotecta…

Recall date

November 10, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0652-2021

FDA classification

Class II

Brand / firm

CryoLife, Inc.

Sold / distributed

Distributed nationwide to GA, AZ, TX, MO, and OK.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.