Class 2 Device Recall BioGlue

• Date Initiated by Firm: May 19, 2017
• Create Date: June 23, 2017
• Recall Status: Terminated on February 08, 2019
• Recall Number: Z-2623-2017
• Recall Event ID: 77369
• PMA Number: P010003
• Product Classification: Glue,surgical,arteries - Product Code MUQ
• Product: BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J
• Code Information: Lot Code 17MJX002, Model/Catalog Number BG3510-5-J
• 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: The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
• FDA Determined Cause: Labeling mix-ups
• Action: Firm notified customer on approximately 06/02/2017 via letter. Instructions included to inspect inventory on hand, to destroy the incorrect courtesy labels and replace them with the correct labels what were shipped.
• Quantity in Commerce: 705 single pack boxes
• Distribution: Product distributed in Japan.
• 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