Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved Recalled by CryoLife, Inc. Due to On November 10, 2020, it was discovered that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CryoLife, Inc. directly.
Affected Products
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.
Quantity: 2 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CryoLife, Inc.
CryoLife, Inc. has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report