BEUDAMED
    FDA Enforcement Class II Ongoing

    Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

    Recall: Z-2538-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2538-2021
    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 A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device

    Reason

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

    Code Info

    Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)

    Distribution

    US Nationwide distribution.

    Quantity

    8170 units