BEUDAMED
    FDA Enforcement Class II Terminated

    SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

    Recall: Z-0967-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0967-2017
    Event ID
    75952
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    July 11, 2016
    Classification Date
    January 9, 2017
    Termination Date
    October 5, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

    Reason

    The product contained a latex catheter instead of a silicone catheter.

    Code Info

    NGAQ4149

    Distribution

    US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA

    Quantity

    2690 units