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
Check against the official notice below — it lists the full affected range.
CryoLife, Inc. is recalling two units of the CryoPatch SG Pulmonary Human Cardiac Patch due to post-processing microbial culture test failures. On November 10, 2020, the company discovered that other allografts processed using the same TRIS saline solution lot had failed microbial culture tests, and this same solution lot was used in processing the recalled patches. The affected patches have model/catalog number SGP020 with serial numbers 11677186, 11679112, and 11681763. The patches were distributed nationwide to hospitals and medical facilities in Georgia, Arizona, Texas, Missouri, and Oklahoma.
The recall involves cryopreserved patches stored in tissue culture medium within a three-pouch packaging system. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Distributed nationwide to GA, AZ, TX, MO, and OK. Quantity: 2 units Lot/code info: Model/Catalog Number: SGP020 Serial Numbers: 11677186, 11679112, and 11681763 UDI: 00877234000485
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.