medical Class II Updated 2019-05-01

CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery Patch

Recalled Product

CryoPatch SG Pulmonary Hemi-Artery Patch

Hazard / Issue

The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.

Issued by

FDA

Distribution: Product was shipped to Texas
Lot/Code Info: Model #: SGPHOO Serial #10685466
View official government recall

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