Events

Recall of Alaris GP Infusion set with Back Check Valve

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 Pty Ltd.

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
    RC-2016-RN-01153-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-09-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01153-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has received an increased rate of reports citing false upstream occlusion alarm of alaris gp sets with back check valve – 63420eb. these errors have been reported at flow rates below 250ml/hour. there is a risk that a clinician will not be able to start an infusion, or the infusion may be stopped due to an alarm, potentially resulting in a delay in therapy.
  • Action
    BD is advising users to inspect inventory and quarantine any stocks of the affected lot numbers. Affected stock can be returned to BD for credit or replacement.

Device

Alaris GP Infusion set with Back Check Valve
  • Model / Serial
    Alaris GP Infusion set with Back Check Valve Reference Number : 63420EBLot Numbers: 1000079, 1000169, 1000177, 1000321 ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd