BEUDAMED
    FDA Enforcement Class III Terminated

    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

    Recall: Z-2333-2016 · Reported August 10, 2016

    Enforcement

    Recall Number
    Z-2333-2016
    Event ID
    74610
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 10, 2016
    Initiation Date
    June 29, 2016
    Classification Date
    August 3, 2016
    Termination Date
    December 5, 2017
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device

    Reason

    Labeling problem

    Code Info

    Lot Number NGZG1722

    Distribution

    Nationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.

    Quantity

    530 units