U.S. FDA

Class A Recall – Polar Care – Medical & Radiation Emitting Device Recalls 

Date Posted August 20, 2008
Recall Number N-0015-2008
Product BREG’s Polar Care 500, Part # 02019; Polar Care 500 Lite, Part # 02020; Polar Care 300, Part #28021.Used for cold therapy after orthopedic surgery.
Code Information All units of the listed models are affected
Recalling Firm/
Manufacturer		 Breg Inc, An Orthofix Company
2611 Commerce Way
Vista, California 92081-8439
For Additional Information Contact Kathleen Barber
760-599-5719
Reason for
Recall		 This Patient Safety Advisory was initiated to remind users of the risk of cold induced injuries and recommend important safety precautions for BREG Polar Care products.
Action Breg sent a Patient Safety Advisory notice “Dear Dr. letter” dated 09/19/2006 to Distributors & Medical Professionals. The purpose of the letter was to re-educate the orthopedic medical community of the risk of cold induced injuries from cold therapy, including Breg Polar Care products, and to recommend important patient safety precautions, such as not using cold therapy on patients with contraindications and providing a written treatment protocol for each patient. Breg sent a letter, dated May 1, 2007 to all customers, explaining that Breg changed the labeling and instructions with simplified graphics.
Quantity in Commerce 718,000
Distribution Nationwide Distribution.
   
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