BEUDAMED
    FDA Recall Terminated

    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).

    Recall: Z-1674-2014 · Initiated April 25, 2014

    Recall

    Recall Number
    Z-1674-2014
    Event Number
    68150
    Firm
    CryoLife, Inc.
    FEI Number
    3001451326
    Product Code
    MUQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 25, 2014
    Posted
    May 30, 2014
    Terminated
    November 10, 2014
    Address
    1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632

    Description

    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).

    Reason

    Serum albumin component monomer failed to meet internally established end of shelf-life specification.

    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.

    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.

    Quantity

    6190 units