BEUDAMED
    FDA Enforcement Class II Terminated

    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.

    Recall: Z-2872-2017 · Reported August 16, 2017

    Enforcement

    Recall Number
    Z-2872-2017
    Event ID
    77733
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 16, 2017
    Initiation Date
    June 2, 2017
    Classification Date
    August 10, 2017
    Termination Date
    July 26, 2021
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or moth other types of urinary catheters, which are intended for use for bladder management including urine drainage, collection and measurement.

    Reason

    Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.

    Code Info

    Product Code 151919; Lot No. NGAS4058

    Distribution

    US Nationwide in the states of CA, CO, FL, IL, IN, LA, MN, MO, NC, NJ, NY, OH, OK, PA, TX, WY, including PR.

    Quantity

    2,350 units