CryoLife Recalls CryoPatch SG Pulmonary Human Cardiac Patch Units
CryoLife, Inc. is recalling two units of CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the recall is driven by confirmed microbial culture test failures, which represents a significant risk of infection or injury.
Plain-English summary
CryoLife, Inc. is recalling two units of the CryoPatch SG Pulmonary Human Cardiac Patch. The recall was initiated after it was discovered on November 10, 2020, that post-processing microbial culture tests failed for other allografts processed using a specific TRIS saline solution lot. This same saline solution lot was used in the processing of the recalled CryoPatch SG units.
The affected product is a cryopreserved human cardiac patch distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk, and pulmonary branch. The specific units involved are identified by Model/Catalog Number SGP020 and Serial Numbers 11677186, 11679112, and 11681763. The UDI for the product is 00877234000485.
The recalled units were distributed nationwide to facilities in Georgia, Arizona, Texas, Missouri, and Oklahoma. Healthcare providers and facilities should check their inventory for these specific serial numbers and contact the recalling firm for instructions on how to handle the affected units.
The recalled product
- 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
- Manufacturer
- CryoLife, Inc.
- Category
- Medical Device — Cardiac Patch
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: SGP020 Serial Numbers: 11677186
- 11679112
- and 11681763 UDI: 00877234000485
Distribution
Part of a larger recall action
This product is one of 2 recalled by CryoLife, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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