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U.S. Department of Health and Human Services

Medical Device Recalls
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  Medical Device Recalls see related information
Date Initiated by Firm September 19, 2006
Create Date August 20, 2008
Recall Status1 Terminated 3
Recall Number N-0015-2008
Recall Event ID 45797
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 CA 92081-8439
For Additional Information Contact Kathleen Barber
760-599-5719
Manufacturer 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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