BEUDAMED
    FDA Enforcement Class II Ongoing

    VGlove NITRILE *** Protect Your Life 100 Patient examination gloves

    Recall: Z-1381-2021 · Reported April 21, 2021

    Enforcement

    Recall Number
    Z-1381-2021
    Event ID
    87447
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    HUBO INTERNATIONAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    April 21, 2021
    Initiation Date
    October 23, 2020
    Classification Date
    April 9, 2021
    Address
    9528 Rush St Ste E, N/A, South El Monte, CA, 91733-1551, United States

    Description

    VGlove NITRILE *** Protect Your Life 100 Patient examination gloves

    Reason

    Package labeled as nitrile gloves, contains latex gloves.

    Code Info

    Lot Number: 0 320 302

    Distribution

    U.S.: CA O.U.S.: None

    Quantity

    28,450 boxes (100 gloves per box)