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CryoLife, Inc. recalls CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Recalled October 24, 2018 · FDA recall Z-0121-2019 · CryoLife
Hazard
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm. · FDA Class II
Units
1 graft
Sold at
US Nationwide in the state of California.
Description
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
Product
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Manufacturer(s)
CryoLife, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →