Events

Recall of Cellplex LivaNova FlexTherm Heater Cooler)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cellplex 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
    21136
  • Event Initiated Date
    2017-02-27
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    Manufacturer conducted a thorough review of the flextherm heater cooler design, which has been marketed since june 2015, and came to conclusion that the design concept does not fully meet user requirements., the device is being discontinued and product voluntarily removed from customer sites.
  • Action
    Product to be returned to supplier

Device

Cellplex LivaNova FlexTherm Heater Cooler)
  • Model / Serial
    Model: 16-70-00, Affected: Serial Numbers: 16E01022, 16E01025, 16E01056, 16E01073, 16E01074, 16E01075, 16E01076 and 16E01095
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd