CryoLife, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0653-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

CryoPatch SG Pulmonary Human Cardiac Patch. The patch 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 patch into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the patch matrix. Finally, the patch is transferred for long-term storage at or below 135¿ C. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch.

Product Classification:

Class II

Date Initiated: November 10, 2020

Date Posted: December 30, 2020

Recall Number: Z-0653-2021

Event ID: 86890

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated