CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model BG3510-5-G
- Recall date
- October 7, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0384-2022
- FDA classification
- Class II
- Brand / firm
- CryoLife, Inc.
- Sold / distributed
- Distribution in the European Union only (Germany/Switzerland)
Why it was recalled
Product is not approved for use in the EU and should not have been distributed in the EU.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
BioGlue Surgical Adhesive, Model BG3510-5-G
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