BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model

FDA device recall Z-0803-2013 · posted 2013-02-12 · Terminated

Recall details

Recalling firm

Breg Inc

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.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

ILO

Quantity affected

44,883 units

Distribution

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

Date initiated

2013-01-14

Date posted

2013-02-12

Date terminated

2013-07-01

Location

Carlsbad, CA