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).
FDA Recall Z-1674-2014 · Posted 2014-05-30
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Recalling FirmCryoLife, Inc.
Recall StatusTerminated
Product CodeMUQ
Date Initiated2014-04-25
Date Terminated2014-11-10
Product Quantity6190 units
Reason for Recall
Serum albumin component monomer failed to meet internally established end of shelf-life specification.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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