Events

Recall of Baxter FOLFusor SV 0.5ml/hr

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

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
    16552
  • Event Initiated Date
    2014-04-17
  • 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
    Manufacturer has continued to investigate complaints for over-infusion and wants to make customers aware that the direction insert states that infusion rates may be up to 10% greater than the nominal (labeled) infusion rate of 0.5ml/hr. recent review of flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal (labeled) infusion rate., baxter is considering options to bring the flow rate into alignment with curent labeling.
  • Action
    Instructions for use to be updated

Device

Baxter FOLFusor SV 0.5ml/hr

Manufacturer

Baxter Healthcare SA (Switzerland)