FDA-Device2021-12-22Class II
BioGlue Surgical Adhesive, Model BG3510-5-G
CryoLife, Inc.
Hazard
Product is not approved for use in the EU and should not have been distributed in the EU.
Sold states
Distribution in the European Union only (Germany/Switzerland)
Affected count
156 5-pack box units
Manufactured in
1655 Roberts Blvd Nw, Kennesaw, GA, United States
Products
BioGlue Surgical Adhesive, Model BG3510-5-G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0384-2022Don't want to check this manually?
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