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U.S. Department of Health and Human Services

Class 2 Device Recall BioGlue Surgical Adhesive

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  Class 2 Device Recall BioGlue Surgical Adhesive see related information
Date Initiated by Firm June 04, 2018
Create Date July 26, 2018
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-2556-2018
Recall Event ID 80276
PMA Number P010003 
Product Classification Glue, surgical, arteries - Product Code MUQ
Product BioGlue Spreader Tip, 12mm, Sterile, RX Only.

Product Usage:
BioGlue is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral , and carotid arteries).
Code Information Model Number BG3510-5-J, Lot Number 18MJX002
Recalling Firm/
Manufacturer		 CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw GA 30144-3632
For Additional Information Contact
770-290-4604
Manufacturer Reason
for Recall		 The CryoLife L6318 (Label, BioGlue 12mm Spreader Tip, Indicator Label 2 1/8" x 1 1/4") was incorrectly applied to the Syringe Applicator Tip pouches and Syringe Spreader Tip pouches were not included in the boxes.
FDA Determined
Cause 2		 Error in labeling
Action CyroLife notified their customers on/about 06/04/2018 via Urgent - Important Product Removal letter. instructions indicated that affected pouches have been returned to CryoLife, Inc. Any questions/clarifications regarding this removal are directed to contact 800-438-8285 or by email to fieldassurance@c ryolife.com.
Quantity in Commerce 855 Total
Distribution Distribution is to 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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