September 12, 2012Medical DevicesFDA
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
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.