BEUDAMED
    FDA Enforcement Class II Completed

    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

    Recall: Z-0667-2022 · Reported March 2, 2022

    Enforcement

    Recall Number
    Z-0667-2022
    Event ID
    89288
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2022
    Initiation Date
    January 27, 2022
    Classification Date
    February 24, 2022
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

    Reason

    There is a potential to leak from the catheter where it connects to the drain bag

    Code Info

    Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)

    Distribution

    US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.

    Quantity

    1620 units