Events

Recall of Avant and Primo2x Families Adult Oxygenator Mounting Brackets

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
    20371
  • Event Initiated Date
    2016-07-12
  • 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
    Following a notice regarding the the disinfection and cleaning of sorin heater cooler systems in june 2015, it has been identified that certain oxygenator mounting brackets that are currently being used with the heater-cooler 3t could be a source of re-contamination of a clean heater-cooler 3t's water circuit and should be replaced. the replacement brackets will have no contact with the heater cooler water circuit.
  • Action
    Product to be returned to supplier

Device

Avant and Primo2x Families Adult Oxygenator Mounting Brackets

Manufacturer

Sorin Group Deutschland GmbH