Device product
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.
Z-0653-2021
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 86890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0653-2021
Official wording
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.
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.
Derived failure modes
-
Unknown
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.