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U.S. Department of Health and Human Services

Class 2 Device Recall BioGlue

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  Class 2 Device Recall BioGlue see related information
Date Initiated by Firm May 19, 2017
Create Date June 23, 2017
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = CRYOLIFE, INC.
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