BEUDAMED
    FDA Recall Completed

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

    Recall: Z-1871-2017 · Initiated March 9, 2017

    Recall

    Recall Number
    Z-1871-2017
    Event Number
    76775
    Firm
    C.R. Bard, Inc.
    FEI Number
    1018233
    Product Code
    EYZ
    Status
    Completed
    Root Cause
    Error in labeling
    Initiated
    March 9, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497

    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.

    Action

    Consignees were notified by letter on/about 03/09/2017.

    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