FDA-Device2019-05-01Class II
CryoPatch SG Pulmonary Hemi-Artery Patch
CryoLife, Inc.
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.
Sold states
Product was shipped to Texas
Affected count
1
Manufactured in
1655 Roberts Blvd Nw, N/A, Kennesaw, GA, United States
Products
CryoPatch SG Pulmonary Hemi-Artery Patch
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1219-2019Don't want to check this manually?
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