Reported Feb 20, 2013 · Terminated
BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490,…
Breg Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breg Inc · 2885 Loker Ave E · Carlsbad, CA · 92010-6626
Is this the product you have?
- BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg
- Date
112012. Model #s: 025100990102330023500249002356024960241002430. Local anesthetic effect
- Lot codes and dates
- Affected product will be identified by date of manufacture from January 2010 through October 2012
- Amount recalled
- 44,883 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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