Recall Z-0653-2021— CryoLife, Inc.

Name: FDA recall Z-0653-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-10

Class II · Terminated

Class II FDA medical device recall by CryoLife, Inc., initiated 2020-11-10, terminated 2021-10-26. It names one FDA 510(k) clearance: K101866. 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.. 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..

Recalling firm: CryoLife, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-10
Terminated: 2021-10-26
Firm location: Kennesaw, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K101866 — CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCHCryolife, Inc.·cleared 2010-07-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.