Events

Recall of Filter for ultrafiltration of water for intravenous

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Gambro Dialysatoren GmbH & Co KG.

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
    22718
  • Event Initiated Date
    2018-03-15
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Reason
    The current instructions for use (ifu) state the ultrafilter has a maximum lifetime usage of 90 days, or 150 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles. in order to reduce the patient risk associated with the occurrence of leaks, the ifu will be updated to reduce the maximum lifetime usage to 60 days, or 100 heat disinfection cycles, with a maximum of 8 sodium carbonate and 12 sodium hypochlorite disinfection cycles when the ultrafilter is used in conjunction with ak96 and ak98 v1 dialysis machines.
  • Action
    Instructions for use to be updated

Device

Filter for ultrafiltration of water for intravenous

Manufacturer

Gambro Dialysatoren GmbH & Co KG