Events

Recall of Klikfit CT Syringe with QFT and 75cm Extension tube

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Imaxeon 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-00173-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00173-1
  • 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
    An issue has been identified with the 75cm extension tube included with the klikfit ct syringe with qft. the coil presentation of the tube causes a pull force that could dislodge or move the connected cannula which can lead to extravasation.
  • Action
    Imaxeon is advising users to inspect stock and quarantine any remaining units. Affected stock can be returned to Imaxeon and replaced with an alternate product.

Device

Klikfit CT Syringe with QFT and 75cm Extension tube
  • Model / Serial
    Klikfit CT Syringe with QFT and 75cm Extension tubeCatalogue Number: ZY6022All lot numbers with an expiry date up to and including November 2020ARTG Number: 127663
  • Manufacturer
    Imaxeon Pty Ltd

Manufacturer

Imaxeon Pty Ltd
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DHTGA