BEUDAMED
    FDA Recall Terminated

    ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609

    Recall: Z-0622-2011 · Initiated September 24, 2010

    Recall

    Recall Number
    Z-0622-2011
    Event Number
    56855
    Firm
    Pfizer Global
    FEI Number
    3008678286
    Product Code
    IMD
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 24, 2010
    Posted
    December 16, 2010
    Terminated
    September 16, 2011
    Address
    5 Giralda Farms, Madison, NJ, 07940

    Description

    ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609

    Reason

    The chemical components contained in the heat wrap may leak directly onto the skin, which could cause skin injury, including burns.

    Action

    Wyeth Consumer Healthcare issued an Urgent Voluntary Medical Device Recall letter dated September 24, 2010 to direct accounts, and issued a press release. The firm is removing the product in question from store shelves and asking consumers who have purchased the product to record the lot number, throw the product away in its entirety without opening the foil pouch and call 1 800 232-3383 for replacement. Direct accounts were instructed to remove the affected product from sale and return it immediately. If they further distributed the product they were instructed to notify their customers of the recall and request return of the products to them credit. Instructions were provided in the event consumers inquired about the recall. A prepaid post card was enclosed to record the quantity on hand to be returned.

    Distribution

    Nationwide Distribution: Throughout the U.S. and Puerto Rico.

    Quantity

    192000 cartons (3 wraps per carton)