Events

Recall of Bard Arctic Sun Temperature Management System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Medivance 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
    17158
  • Event Initiated Date
    2014-08-11
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Reason
    Two adverse events have been reported to the manufacturer. in each instance, a temperature simulator key was connected to the patient temperature cable instead of the patient temperature probe. due to the false patient temperature reading from the temperature simulator key, improper targeted temperature therapy was delivered to the patients by the arctic sun® 5000.
  • Action
    Manufacturer to issue advice regarding use

Device

Bard Arctic Sun Temperature Management System
  • Model / Serial
    Model: Catalogue Numbers: 5000-01, 748-00, 771-00, Affected: All lots
  • Manufacturer
    Medivance Inc

Manufacturer

Medivance Inc