BEUDAMED
    FDA Recall Terminated

    Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process.

    Recall: Z-1878-2009 · Initiated July 17, 2009

    Recall

    Recall Number
    Z-1878-2009
    Event Number
    52708
    Firm
    Luv N' Care Ltd
    FEI Number
    2381321
    Product Code
    KKO
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    July 17, 2009
    Posted
    August 12, 2009
    Terminated
    February 28, 2013
    Address
    3030 Aurora Ave, Fl 2nd, Monroe, LA, 71201-7295

    Description

    Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process.

    Reason

    Gel filled teethers were found to contain to contain Bacillus circulans and Bacillus subtilis.

    Action

    The firm initiated their recall by telephone and email, and followed with letters to their consignees directing a recall to the consumer level. Consumers are urged to stop using the affected product and discard or return to the place of purchase. Consumers with questions about the recall may contact Luv N' Care, LTD by calling 1-800-256-2399. The firm issued a Press Release on July 17, 2009. Press Release about this recall is located on the website address: http://www.fda.gov/Safety/Recalls/ucm172689.htm.

    Distribution

    Worldwide Distribution -- US (states of NY, IA, WI, IL, FL, NE, OH, MI, TX, NY, RI, and VA), Canada, Haiti, West Indies, Surinam, Antilles, Uruguay, Mexico, Bermuda, Canada, Dominican Republic, Dutch West Indies, Bahamas, North Antilles and Paraguay.

    Quantity

    546,320 units