Recall Z-1989-2009 ยท ILO Pack, Hot Or Cold, Water Circulating
Breg Inc, An Orthofix Company
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.
| Date | Sep 4, 2009 (initiated Jun 18, 2009) |
| Status | Terminated |
| 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. |
| Root cause | 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 cust |
| Quantity | 20,439 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.