Events

Recall of ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - MODEL 5000 CONTROL MODULE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA INC..

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
    23036
  • Event Risk Class
    II
  • Event Initiated Date
    2017-08-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Bard is informing customers that use of the arctic sun temperature management system in excess of 2000 system hours without conducting preventative maintenance may result in failure of certain components of the system particularly in relation to the mixing pump which runs continuously during operation. failure of the mixing pump may cause the device to cease to function as intended resulting in no availability of cooling or rewarming therapy for the patient.

Device

ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM - MODEL 5000 CONTROL MODULE
  • Model / Serial
    Model Catalog: 5000-00-00 (Lot serial: >10 NUMBERS CONTACT MFR)
  • Product Description
    ARCTIC SUN 5000 TEMP MANAGEMENT SYSTEM
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.