BEUDAMED
    FDA Enforcement Class II Ongoing

    GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

    Recall: Z-0096-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0096-2024
    Event ID
    93045
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ansell Healthcare Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 18, 2023
    Initiation Date
    August 3, 2023
    Classification Date
    October 11, 2023
    Address
    2301 Robb Dr, N/A, Reno, NV, 89523-1901, United States

    Description

    GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: 20685255 through 20685290

    Reason

    Some surgical glove sterile pouches were not completely sealed.

    Code Info

    Lot: 2203434204, REF/UDI-DI: 20685255/00884792385206, 20685260/00884792385213, 20685265/00884792385220, 20685270/00884792385237, 20685275/00884792385244, 20685280 00884792385251, 20685285 00884792385268, 20685290 00884792385275.

    Distribution

    Worldwide - US Nationwide distribution in the states of IN, OH, NY, VA, IL, TN, GA, NY, SC, WI, FL and the country of CA.

    Quantity

    1511