BEUDAMED
    FDA Enforcement Class II Ongoing

    NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

    Recall: Z-0097-2024 · Reported October 18, 2023

    Enforcement

    Recall Number
    Z-0097-2024
    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

    NOVAPLUS GAMMEX NON-LATEX PI GREEN Surgical gloves, REF: V20685255 through V20685290

    Reason

    Some surgical glove sterile pouches were not completely sealed.

    Code Info

    Lot: 2203434604, REF/UDI-DI: V20685255/10014566400553, V20685260/10014566400607, V20685265/10014566400652, V20685270/10014566400706, V20685275/10014566400751, V20685280/10014566400805, V20685285/10014566400850, V20685290/10014566400904.

    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

    378