BEUDAMED
    FDA Enforcement Class II Terminated

    Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.

    Recall: Z-0616-2013 · Reported January 2, 2013

    Enforcement

    Recall Number
    Z-0616-2013
    Event ID
    63497
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brookstone Company, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 2, 2013
    Initiation Date
    November 2, 2012
    Classification Date
    December 27, 2012
    Termination Date
    June 13, 2013
    Address
    1 Innovation Way, N/A, Merrimack, NH, 03054-4873, United States

    Description

    Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (Blue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use.

    Reason

    Additional Warning Statement to prevent burns to the skin

    Code Info

    All lot codes

    Distribution

    Nationwide Distribution.

    Quantity

    109,956 units