Events

Recall of Machines for extracorporeal blood treatment -2008, 4008, 5008, Genius, Prometheus, etc

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Fresenius Medical Care AG & Co KGaA.

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
    23312
  • Event Initiated Date
    2018-07-09
  • 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: Fresenius Medical Care Australia Pty Ltd (NZ), 60 Pavillion Drive, Airport Oaks, AUCKLAND
  • Reason
    The manufacturer has undertaken a review of the hazards identified with the use of the 5008 paed therapy system and determined that it is no longer possible to uphold the currently defined lower limit of 10 kg of body weight in the intended use for a safe application. as a result, the manufacturer are limiting the intended use to >17 kg of body weight.
  • Action
    Instructions for use to be updated

Device

Machines for extracorporeal blood treatment -2008, 4008, 5008, Genius, Prometheus, etc

Manufacturer

Fresenius Medical Care AG & Co KGaA