BEUDAMED
    FDA Enforcement Class II Terminated

    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.

    Recall: Z-0804-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0804-2013
    Event ID
    64177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Breg Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 20, 2013
    Initiation Date
    January 14, 2013
    Classification Date
    February 12, 2013
    Termination Date
    July 1, 2013
    Address
    2885 Loker Ave E, Carlsbad, CA, 92010-6626, United States

    Description

    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. 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.

    Code Info

    Affected product will be identified by date of manufacture from January 2010 through October 2012

    Distribution

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

    Quantity

    44,883 units