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U.S. Department of Health and Human Services

Class 2 Device Recall Polar Care Kodiak

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  Class 2 Device Recall Polar Care Kodiak see related information
Date Initiated by Firm June 18, 2009
Date Posted September 04, 2009
Recall Status1 Terminated 3 on March 28, 2011
Recall Number Z-1989-2009
Recall Event ID 52775
Product Classification Water Circulating Hot or Cold Pack - Product Code ILO
Product Power Supply Accessory (model AD-0660G)

Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall socket and provides low voltage power to the Kodiak unit. The power supply is not used with other Polar Care models such as PC300 and PC500.
Code Information Lots 3508, 3908, 4308, and 4808.
Recalling Firm/
Manufacturer		 Breg Inc, An Orthofix Company
2611 Commerce Way
Vista CA 92081-8439
For Additional Information Contact
800-321-0607
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Employee error
Action An Urgent: Medical Device Recall Notification was sent to customers on June 18, 2009. FOR USERS: Customers are advised to immediately open all unused Kodiak cold therapy units and inspect the lot code of the Power Supply included with the Kodiak unit. If the lot code is 3508, 3908, 4308, or 4808, then remove the power supply, cut the cord using scissors and discard. Call Breg Customer Service for a replacement: 1-800-321-0607. Complete and return the response form ASAP. FOR DISTRIBUTORS: Send Breg your distribution information, including contact and quantities. Breg will notify your customers of the recall directly.
Quantity in Commerce 20,439
Distribution Worldwide Distribution
Total Product Life Cycle TPLC Device Report
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.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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