Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold

FDA device recall Z-1989-2009 · posted 2009-09-04 · Terminated

Recall details

Recalling firm

Breg Inc, An Orthofix Company

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.

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.

Root cause

Employee error

Status

Terminated

Product code

ILO

Quantity affected

20,439

Distribution

Worldwide Distribution

Date initiated

2009-06-18

Date posted

2009-09-04

Date terminated

2011-03-28

Location

Vista, CA