Events

Recall of Secondary Set Oncology

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-2017-RN-00465-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00465-1
  • 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, becton dickenson (bd) has received reports of cracking of the secondary set back check valve male luer resulting in leaking of the infusion fluid. during use of the set, a leak occurs at the connection between the needle free valve and back check valve (bcv) connection. leakages can cause delay of infusion, interruption of infusion, exposure to infusates, or under-infusion. bd has not received any reports of serious injury or death associated with the separation or leaks. bd is not aware of any report of injury attributed to this defect in australia.
  • Action
    BD is advising users to discontinue use of and segregate the identified units, and then return to BD. Replacement stock or credit will be provided.

Device

Secondary Set Oncology
  • Model / Serial
    Secondary Set Oncology Catalogue Number: 72951NE Lot Numbers: 1000089, 1000129, 1000208, 1000468, 1000469, 1000687 and 1000713ARTG Number: 125916
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd