Events

Recall of Sorin Heater Cooler Systems 1T and 3T devices

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Sorin Group Deutschland GmbH.

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
    18718
  • Event Initiated Date
    2015-06-23
  • 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
    Sorin has become aware that the actual disinfection practices and the water maintenance that some users have been performing are not always conducted according to the instructions for use. without vigilant performance of the disinfection and maintenance procedures per the instructions for use, organisms can multiply in a heater cooler device and potentially form biofilm.
  • Action
    Instructions for use to be updated

Device

Sorin Heater Cooler Systems 1T and 3T devices

Manufacturer

Sorin Group Deutschland GmbH