Events

Recall of CareFusion Alaris GP Infusion System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by CareFusion Switzerland 317 Sarl.

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
    13823
  • Event Initiated Date
    2012-11-23
  • 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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Reason
    The manufacturer has determined that the alaris gp infusion system produces very small air bubles (less than 50ul) which are too small to trigger the lowest configurable air-in-line detection alarm being 50-500ul as configured by the user, or 1ml over 15 minutes.
  • Action
    Instructions for use to be updated

Device

CareFusion Alaris GP Infusion System
  • Model / Serial
    Model: Models: 80063UN01, 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G, Affected: All pumps
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl