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U.S. Department of Health and Human Services

Class 2 Device Recall BioGlue Surgical Adhesive (BioGlue)

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 Class 2 Recall
BioGlue Surgical Adhesive (BioGlue)
see related information
Date Posted May 30, 2014
Recall Status1 Terminated on November 10, 2014
Recall Number Z-1674-2014
Recall Event ID 68150
Premarket Approval
PMA Number
P010003
Product Classification Glue,Surgical,Arteries - Product Code MUQ
Product BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (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 of large vessels (such as aorta, femoral, and carotid arteries).
Code Information 12MUV034, 12MUX035, 12MUV069, 12MUV037, 12MUV038, 12MUV040, 12MUV041, 12MUV042, 12MUV043, 12MUV044, 12MUV045, 12MUV046, 12MUV047, 12MUV048, 12MUV049, 12MUV050, 12MUV051, 12MUV052, 12MUV053, 12MUV054, 12MUV055, 12MUV056, 12MUV057, 12MUV058, 12MUV059, 12MUV060, 12MUV061, 12MUV062, 12MUV063, 12MUV064, 12MUV065, 12MUV067, 12MUV068, 12MUV069, 12MUV070, 12MUV071, 12MUV072, 12MUV073, 12MUV074, 12MUV075, 12MUV076, 13MUV001, 13MUV002, 13MUV003, 13MUV004,
Recalling Firm/
Manufacturer
CryoLife, Inc.
1655 Roberts Blvd NW
Kennesaw, Georgia 30144-3632
For Additional Information Contact Sandra O'Reilly
770-419-3355
Manufacturer Reason
for Recall
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action All consignees were notified of the voluntary actions by issuance of Field Correction/Removal Notice on April 24, 2014. This notices states which lot numbers are to be returned, and which lot numbers can be relabeled with a corrected expiration date.
Quantity in Commerce 6190 units
Distribution Distributed Nationwide including Puerto Rico and the states of AL, AK,AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NM , NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MUQ and Applicant = CRYOLIFE, INC.
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