Reported Sep 12, 2012 · Terminated
Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier…
Breg Inc., An Orthofix Company
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, An Orthofix Company · 2885 Loker Ave E · Carlsbad, CA · 92010-6626
Is this the product you have?
- Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
- Lot codes and dates
- Lot # D101564
- Amount recalled
- 502 units
Where it was sold
- Nationwide
Why it was recalled
This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010" instead of 0.020". This change in thickness makes the dressing thinner, less durable and subject to tearing. The product is mislabeled.
This product could cause temporary or reversible health problems — stop using it.
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