Events

Recall of CareFusion Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps

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
    14791
  • Event Initiated Date
    2013-06-11
  • 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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Reason
    The manufacturer has identified an increased occurrence of stepper motor stalls with selected models of alaris gp infusion pump. it has been determined that these stalls are due to the stepper motor's front and rear bearings which may not perform as designed after a period of use causing the pump to stop infusing.
  • Action
    Product to be modified

Device

CareFusion Alaris GP, GP Guardrails, GP Plus & GP Plus Guardrails Infusion Pumps
  • Model / Serial
    Model: Models: 80263UN01, 80263UN01-G, 9002MED01, 9002MED01-G, Affected: Pumps manufactured between Dec 2009 and Jan 2012
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl