CryoPatch SG Pulmonary Human Cardiac Patch. The patch recall: Contamination
CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost…
Why was CryoPatch SG Pulmonary Human Cardiac Patch. The patch 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485
- Product
- CryoPatch SG Pulmonary Human Cardiac Patch. The patch is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost…
- Recalling firm
- CryoLife, Inc.
- Quantity
- 2 units
- Distribution
- Distributed nationwide to GA, AZ, TX, MO, and OK.
- Recall date
- December 30, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)