Events

Recall of Device Recall BREG Cold Therapy Combination Units

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Breg Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64177
  • Event Risk Class
    Class 2
  • Event Number
    Z-0803-2013
  • Event Initiated Date
    2013-01-14
  • Event Date Posted
    2013-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115498
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pack, hot or cold, water circulating - Product Code ILO
  • 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.

Device

Device Recall BREG Cold Therapy Combination Units
  • Model / Serial
    Affected product will be identified by date of manufacture from January 2010 through October 2012.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
  • Product 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.
  • Manufacturer
    Breg Inc

Manufacturer

Breg Inc