BEUDAMED
    FDA Recall Terminated

    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

    Recall: Z-0803-2013 · Initiated January 14, 2013

    Recall

    Recall Number
    Z-0803-2013
    Event Number
    64177
    Firm
    Breg Inc
    FEI Number
    1000125378
    Product Code
    ILO
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    January 14, 2013
    Posted
    February 12, 2013
    Terminated
    July 1, 2013
    Address
    2885 Loker Ave E, Carlsbad, CA, 92010-6626

    Description

    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

    Reason

    The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.

    Action

    The firm, BREG, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product; complete the Return Response Form by email, Fax or mail; and contact Breg for a Return Authorization for the affected product and request replacement by contacting Breg Customer Care at 800-321-0607. Note: response is required even if you have no affected inventory. Should you have any questions regarding this communication or need to report an adverse event, please contact Breg Customer Care at 800-321-0607.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.

    Quantity

    44,883 units