BEUDAMED
    FDA Enforcement Class II Ongoing

    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

    Recall: Z-2527-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2527-2021
    Event ID
    88499
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C.R. Bard Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 5, 2021
    Classification Date
    September 23, 2021
    Address
    8195 Industrial Blvd NE, Covington, GA, 30014-1497, United States

    Description

    Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

    Reason

    There is potential for packaging defects that may impact the sterile barrier.

    Code Info

    Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)

    Distribution

    US Nationwide distribution.

    Quantity

    5950 units