CryoValve SG Pulmonary Human Heart Valve. The valve 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 va
Check against the official notice below — it lists the full affected range.
CryoLife, Inc. is recalling three units of CryoValve SG Pulmonary Human Heart Valve due to post-processing microbial culture test failures discovered on November 10, 2020. The affected valves were processed using a specific lot of TRIS saline solution that also showed microbial culture test failures in other allografts. The recalled units have serial numbers 11685214, 11685554, and 11682491 (Model/Catalog Number SGPV00) and were distributed nationwide to Georgia, Arizona, Texas, Missouri, and Oklahoma.
The recall source does not specify what action affected consumers 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: 3 units Lot/code info: Model/Catalog Number: SGPV00 Serial Numbers: 11685214, 11685554, and 11682491 UDI: 00877234000447
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.