FDA-Device2013-02-20Class II

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.

Breg Inc
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.

Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
Affected count
44,883 units
Manufactured in
2885 Loker Ave E, Carlsbad, CA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2013

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