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
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
packaging which may compromise product sterility