BEUDAMED
    FDA Enforcement Class II Completed

    SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

    Recall: Z-1871-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1871-2017
    Event ID
    76775
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 26, 2017
    Initiation Date
    March 9, 2017
    Classification Date
    April 20, 2017
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

    Reason

    Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

    Code Info

    Product Code: A300316A, Lot number: NGAV2400

    Distribution

    CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA.

    Quantity

    5030 units