Events

Recall of Sorin 1T /3T FlexTherm Systems

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
    20357
  • Event Initiated Date
    2016-07-08
  • 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
    The instructions for use for the 1t and 3t/flextherm system prescribe the addition of 50ml and 150ml respectively of medical grade 3% hydrogen peroxide to the filtered tap water in the device, which results in a maximum concentration of approximately 330ppm. the purpose of adding the hydrogen peroxide is to prevent microbial growth between the regular cleaning / disinfection cycles performed every 2 weeks., the manufacturer has determined that plastic heat-exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow for diffusion of some quantity of hydrogen peroxide during a typical procedure.
  • Action
    Manufacturer to issue advice regarding use

Device

Sorin 1T /3T FlexTherm Systems
  • Model / Serial
    Model: 16-02-50 16-02-80 16-02-91 16-02-82 16-02-83 16-02-85 16-02-95 and 16-70-00, Affected:
  • Manufacturer
    Sorin Group Deutschland GmbH

Manufacturer

Sorin Group Deutschland GmbH