FDA Device

BioGlue Surgical Adhesive, Model BG3510-5-G

Hazard

Product is not approved for use in the EU and should not have been distributed in the EU.

What You Should Do

Remedy

A customer letter titled "Urgent Field Safety Notice BioGlue" was issued 10/07/2021 to the impacted consignee. All product is to be returned for final disposition. A customer reply letter should be completed and submitted to the recalling firm.

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Products

BioGlue Surgical Adhesive, Model BG3510-5-G
Brand
CryoLife, Inc.
UPC
Model BG3510-5-G, Lot BG000255

Units Affected

156 5-pack box units

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