Recall Z-1989-2009
Breg Inc, An Orthofix Company · initiated June 18, 2009
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.
Codes / lots: Lots 3508, 3908, 4308, and 4808.
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: Employee error
Action taken
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.
Details
- Recall number
- Z-1989-2009
- Initiated
- June 18, 2009
- Posted by FDA
- September 4, 2009
- Terminated
- March 28, 2011
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Quantity
- 20,439
- Distribution
- Worldwide Distribution
- Recalling firm
- Breg Inc, An Orthofix Company, Vista, CA