BEUDAMED
    FDA Enforcement Class II Terminated

    The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry

    Recall: Z-2160-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2160-2012
    Event ID
    62645
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Afassco Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    August 15, 2012
    Initiation Date
    February 8, 2012
    Classification Date
    August 8, 2012
    Termination Date
    January 14, 2014
    Address
    228 W Chestnut St, Orrville, OH, 44667-1904, United States

    Description

    The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry

    Reason

    The firm is initiating a field correction because the product(s) were missing the Latex Warning Label. Afassco Inc. is implementing a voluntary field correction for MULTI-COLORED FINGER COTS because product lacked the warning label: "CAUTION: This product contains Natural Rubber Latex which may cause allergic reactions."

    Code Info

    Recall involves finger cots model #s 5017 and 5018. There is no coding of the boxes or the cots

    Distribution

    Nationwide Distribution including CA, FL. GA. HI, IL, IN, MI, NH, NV, TN, TX, and WV.

    Quantity

    1956 Boxes