FDA Recall Terminated

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.

Recall: Z-1989-2009 · Initiated June 18, 2009

Recall

Recall Number
Z-1989-2009
Event Number
52775
Firm
Breg Inc, An Orthofix Company
FEI Number
1000125378
Product Code
ILO
Status
Terminated
Root Cause
Employee error
Initiated
June 18, 2009
Posted
September 4, 2009
Terminated
March 28, 2011
Address
2611 Commerce Way, Vista, CA, 92081-8439

Description

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.

Reason

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.

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.

Distribution

Worldwide Distribution

Quantity

20,439