CryoLife, Inc. recalls BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
- Recall date
- May 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2623-2017
- FDA classification
- Class II
- Brand / firm
- CryoLife, Inc.
- Sold / distributed
- Product distributed in Japan.
Why it was recalled
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
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/Catalog Number BG3510-5-J
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