Breg · Model Kodiak Cold Therapy
• Proven reliability and effectiveness • Easy to use, intuitive design • Customized Inelli-Flo pads provide temperature control specific to each treatment area resulting in superior coverage and comfort • Provides motorized cold treatment for 6-8 hours Examples of Use: • Post Operative • Arthroscopic Procedures • Reconstructive Procedures • Plastic Surgery • General Surgery • Post-Trauma • Chronic Pain • Physical Therapy
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They may not have been sealed prior to sterilization. Products with unsealed pouches will be non-sterile.
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 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.
Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip.
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