Events

Recall of 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 303 Inc.

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
    22023
  • Event Initiated Date
    2017-09-26
  • 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 received reports of customers experiencing a system error (error code: 255-16- 275) with alaris system pc unit model 8015 that can result in interruption of infusions.
  • Action
    Instructions for use to be updated

Device

Infusion Pumps
  • Model / Serial
    Model: , Affected: Alaris™ System Point of Care unit (PC unit), Model 8015 using software version 9.12 and greater
  • Manufacturer
    CareFusion 303 Inc

Manufacturer

CareFusion 303 Inc