BEUDAMED
    FDA Enforcement Class II Ongoing

    Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

    Recall: Z-0838-2022 · Reported April 6, 2022

    Enforcement

    Recall Number
    Z-0838-2022
    Event ID
    89691
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ansell Healthcare Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 6, 2022
    Initiation Date
    February 19, 2022
    Classification Date
    March 30, 2022
    Address
    2301 Robb Dr, N/A, Reno, NV, 89523-1901, United States

    Description

    Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

    Reason

    Transport company failed to stop at the border for required FDA inspection.

    Code Info

    Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

    Distribution

    U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

    Quantity

    74 cases