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Breg Inc, An Orthofix Company recalls Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier be
Recalled September 12, 2012 · FDA recall Z-2326-2012 · Breg Inc, An Orthofix
Hazard
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. · FDA Class II
Units
502 units
Sold at
Worldwide distribution: USA (nationwide) and country of: Nova Scotia.
Description
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.
Product
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.
Manufacturer(s)
Breg Inc, An Orthofix Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →