FDAFDA · Food and drugs·Recall number Z-0804-2013
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.
Published February 20, 2013 · Recall initiated: January 14, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Breg Inc
- Distributor
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Singapore, Chile, Latvia.
- Lot
- Affected product will be identified by date of manufacture from January 2010 through October 2012
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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