Events

Recall of Sorin (Cellplex) 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
    21416
  • Event Initiated Date
    2017-05-15
  • 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 has completed the development of and obtained ce mark for a solution that mitigates against contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. this solution will be implemented in manufacturing, and units currently in use in the field will undergo an upgrade on-site by the obex field service engineer. although this solution is less necessary when the 3t device's water system is maintained according to the ifu, the field upgrade will mitigate against the reasonably foreseeable hazard of accidental contamination and poor maintenance practices.
  • Action
    Product to be modified

Device

Sorin (Cellplex) Heater Cooler

Manufacturer

Cellplex Pty Ltd