Events

Recall of Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia Pty Ltd.

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
    RC-2016-RN-01290-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01290-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    An additional warning is to be included in the operator's manual with the advice that the arctic sun temperature management system is not to be used in the operating room environment. this is to address concerns regarding the potential for non-tuberculous mycobacterium (ntm) bacterial transmission to a patient based on use of the device in operating rooms and sterile fields under existing labelling. the probability of harm to a patient is considered remote.
  • Action
    Bard is providing customers with operator's manual addendum which contains the additional warning that the Arctic Sun Temperature Management System is not intended for use in the operating room environment.

Device

Arctic Sun Temperature Management System (used for regulating the temperature and circulation of ...
  • Model / Serial
    Arctic Sun Temperature Management System (used for regulating the temperature and circulation of water to a vest worn by the patient)Arctic Sun 2000 Temperature Management System (230VAC)Product Code: 2000-03Arctic Sun 5000 Temperature Management System (220-240 V Australia)Product Code: 5000-01-03ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd