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.
FDA Recall Z-1989-2009 · Posted 2009-09-04
Recalling FirmBreg Inc, An Orthofix Company
Recall StatusTerminated
Product CodeILO
Date Initiated2009-06-18
Date Terminated2011-03-28
Product Quantity20,439
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Worldwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.