BEUDAMED
    FDA Recall 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 · Initiated February 8, 2012

    Recall

    Recall Number
    Z-2160-2012
    Event Number
    62645
    Firm
    Afassco Inc
    FEI Number
    3017657529
    Product Code
    FQM
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 8, 2012
    Posted
    August 8, 2012
    Terminated
    January 14, 2014
    Address
    228 W Chestnut St, Orrville, OH, 44667-1904

    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."

    Action

    Afassco sent a Field Correction Notice to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Labels have been included with the notices that the firm will be sending to their distributors. The distributors were asked to examine their inventory and affix the caution label to the boxes of affected product. If additional warning labels are needed, they may contact Afassco (800-441-6774) for additional labels. If they have further distributed these products, they should notify consignees of the field correction. Their notification to their customers may be enhanced by including a copy of the notice sent to them. The recall should be carried out to the user level. For any questions customers may call 1-880-441-6774. For questions regarding this recall call 775-783-3555.

    Distribution

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

    Quantity

    1956 Boxes