FDA-Device2018-10-24Class II
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
CryoLife, Inc.
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.
Sold states
US Nationwide in the state of California.
Affected count
1 graft
Manufactured in
1655 Roberts Blvd Nw, N/A, Kennesaw, GA, United States
Products
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2019Don't want to check this manually?
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