BEUDAMED
    FDA Enforcement Class II Terminated

    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671

    Recall: Z-1358-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1358-2015
    Event ID
    70666
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    January 30, 2015
    Classification Date
    April 1, 2015
    Termination Date
    August 1, 2016
    Address
    8195 Industrial Blvd Ne, N/A, Covington, GA, 30014-1497, United States

    Description

    Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671

    Reason

    Potential breach of the sterile barrier packaging.

    Code Info

    Lot Numbers NGYJ0603 and NGYJ1671

    Distribution

    Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.

    Quantity

    9,620 units