Events

Recall of Device Recall Polar Care Kodiak

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Breg Inc, An Orthofix Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52775
  • Event Risk Class
    Class 2
  • Event Number
    Z-1989-2009
  • Event Initiated Date
    2009-06-18
  • Event Date Posted
    2009-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83978
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Water Circulating Hot or Cold Pack - Product Code ILO
  • 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.

Device

Device Recall Polar Care Kodiak
  • Model / Serial
    Lots 3508, 3908, 4308, and 4808.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product 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.
  • Manufacturer
    Breg Inc, An Orthofix Company

Manufacturer

Breg Inc, An Orthofix Company