Events

Field Safety Notices about ARCTIC SUN

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Bard Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    The tag supplement provides advice that regular maintenance and maintenance of the arctic sun® 5000 temperature monitoring system is recommended to reduce the likelihood of failure of certain components. this letter also details the preventative maintenance program offered by bard to assist in the regular servicing and maintenance of the device. this is not a product recall, and bard does not require you to withdraw from the market and return any unit as a result of this notice.

Device

ARCTIC SUN
  • Model / Serial
    ARCTIC SUN® 5000 Temperature Control System (220-240V for Europe) 5000-01-01 ARCTIC SUN® 5000 Temperature Control System (220-240V for UK) 5000-01-02 ARCTIC SUN® 5000 Temperature Control System (230 V for Switzerland) 5000-01-07 ARCTIC SUN® 5000 Temperature Control System (230 V for South Africa) 5000-01-08
  • Manufacturer
    Bard Limited

Manufacturer

Bard Limited