Class 2 Device Recall BREG Sterile Polar Pads

• Date Initiated by Firm: January 14, 2013
• Date Posted: February 12, 2013
• Recall Status: Terminated on July 01, 2013
• Recall Number: Z-0804-2013
• Recall Event ID: 64177
• 510(K)Number: K920581
• Product Classification: Pack, hot or cold, water circulating - Product Code ILO
• Product: 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.
• Code Information: Affected product will be identified by date of manufacture from January 2010 through October 2012
• Recalling Firm/ Manufacturer: Breg Inc; 2885 Loker Ave E; Carlsbad CA 92010-6626
• For Additional Information Contact: Carol Emerson; 800-321-0607
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Packaging
• 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.
• Quantity in Commerce: 44,883 units
• Distribution: Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ILO