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CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery Patch
Recalled May 1, 2019 · FDA recall Z-1219-2019 · CryoLife
Hazard
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. · FDA Class II
Units
1
Sold at
Product was shipped to Texas
Description
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.
Product
CryoPatch SG Pulmonary Hemi-Artery Patch
Manufacturer(s)
CryoLife, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →