Class 2 Device Recall BioGlue

• Date Initiated by Firm: October 07, 2021
• Create Date: December 15, 2021
• Recall Status: Terminated on October 23, 2023
• Recall Number: Z-0384-2022
• Recall Event ID: 88929
• PMA Number: P010003
• Product Classification: Glue, surgical, arteries - Product Code MUQ
• Product: BioGlue Surgical Adhesive, Model BG3510-5-G
• Code Information: Model BG3510-5-G, Lot BG000255
• FEI Number: 3001451326
• Recalling Firm/ Manufacturer: CryoLife, Inc.; 1655 Roberts Blvd Nw; Kennesaw GA 30144-3632
• For Additional Information Contact: 770-419-3355
• Manufacturer Reason for Recall: Product is not approved for use in the EU and should not have been distributed in the EU.
• FDA Determined Cause: No Marketing Application
• Action: 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.
• Quantity in Commerce: 156 5-pack box units
• Distribution: Distribution in the European Union only (Germany/Switzerland)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MUQ