Events

Recall of Renal Dialyser, peritonela unit_11226_Zurich (Singapore)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Baxter Healthcare Corporation SA.

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
    21674
  • Event Initiated Date
    2017-07-11
  • 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 manufacturer has been made aware that users may not be following the instructions in the operator's manual and incorrectly opening disposable set packaging while setting up their peritoneal dialysis (pd) therapy, damaging the cassettes for the homechoice or homechoice pro cyclers.
  • Action
    Instructions for use to be updated

Device

Renal Dialyser, peritonela unit_11226_Zurich (Singapore)
  • Model / Serial
    Model: , Affected: HomeChoice PRO Automated PD Cycler, 230V, HomeChoice Claria APD System, 115V/230V
  • Manufacturer
    Baxter Healthcare Corporation SA

Manufacturer

Baxter Healthcare Corporation SA