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Breg Inc recalls BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Mode
Recalled February 20, 2013 · FDA recall Z-0803-2013 · Breg
Hazard
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 Class II
Units
44,883 units
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
Description
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.
Product
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(s)
Breg Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →