Device Recall BREG Cold Therapy Combination Units

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

Physical Medicine Devices

2

No

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

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.