BEUDAMED
    FDA Enforcement Class II Terminated

    MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.

    Recall: Z-0051-2021 · Reported October 14, 2020

    Enforcement

    Recall Number
    Z-0051-2021
    Event ID
    86352
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ansell Healthcare Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2020
    Initiation Date
    August 19, 2020
    Classification Date
    October 2, 2020
    Termination Date
    November 3, 2021
    Address
    2301 Robb Dr, N/A, Reno, NV, 89523-1901, United States

    Description

    MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.

    Reason

    Examination gloves were shipped inadvertently, without to verify barrier integrity.

    Code Info

    Lot: 2003LG, Batch: 20035314LG

    Distribution

    U.S. Nationwide distribution including in the states of IL, OK, WI, PA, TX, OH, MI, IN, VA, AR, KS, MO, NV, OR, FL, QC, NJ, NE, KY, AL, TN, LA, NY, SC, MS, MD, CA, GA, SD.

    Quantity

    1312 Cases