Events

Recall of Sorin S3 Heater Cooler

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
    17069
  • Event Initiated Date
    2014-07-30
  • 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
    Newly identified risk for cardiac surgery patients whereby some patients have been infected with a slow growing mycobacterium chimaera. this organism is found in water including tap water sources., important to review hygiene and surgical practices in the cardiac surgery theatre. this review should include sampling and monitoring programs for water sources solution preparations and systems that use water in the cardiac surgery theatre. among these water systems, heater cooler device(s) need strict adherence to the cleaning disinfection and maintenance according to the operator manual for sorin devices.
  • Action
    Manufacturer to issue advice regarding use

Device

Sorin S3 Heater Cooler

Manufacturer

Sorin Group Deutschland GmbH