BioGlue Surgical Adhesive recall
BioGlue Surgical Adhesive, Model BG3510-5-G
Why was BioGlue Surgical Adhesive recalled?
Product is not approved for use in the EU and should not have been distributed in the EU.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model BG3510-5-G, Lot BG000255
- Product
- BioGlue Surgical Adhesive, Model BG3510-5-G
- Recalling firm
- CryoLife, Inc.
- Quantity
- 156 5-pack box units
- Distribution
- Distribution in the European Union only (Germany/Switzerland)
- Recall date
- December 22, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)