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Recall Observatory FDA recall evidence

Device 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.

Z-0804-2013

January 14, 2013

Class II

Product summary

Firm
Breg Inc
Event
Event 64177
Status
Terminated
Classification
Class II
Quantity
44,883 units
Official record key
device-enforcement:Z-0804-2013

Official wording

Reason: 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.

Code information: Affected product will be identified by date of manufacture from January 2010 through October 2012

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

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    packaging which may compromise product sterility