Breg · Model Polar Care Glacier
• High flow rates ensure even temperature distribution • Whisper-quiet pump technology allows your patient to rest easy • Durable, powerful construction provides peace of mind • Best-in-class therapy time and weight balance increases a nurse's efficiency • Temperature control allows the physician to adjust the protocol to the individual patient Examples of Use: • Post Operative • Arthroscopic Procedures • Reconstructive Procedures • Plastic Surgery • General Surgery • Post-Trauma • Chronic Pain • Physical Therapy
Synced live from the FDA openFDA API.
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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