Events

Recall of VTI Bayonet 20 MHz Doppler Probe (used for the intraoperative and transcutaneous critical evaluation of blood flow)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare 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-2014-RN-00607-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00607-1
  • 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, vascular technology, has identified a potential risk with the packaging for the vti bayonet doppler probe. a probe had penetrated the sterile barrier, possibly rendering the device unsterile. this represents a potential safety hazard, which could lead to infection.
  • Action
    Customers are asked to determine if any unused stock exists at their site. Life Healthcare representative will collect any unused stock.

Device

VTI Bayonet 20 MHz Doppler Probe (used for the intraoperative and transcutaneous critical evaluat...
  • Model / Serial
    VTI Bayonet 20 MHz Doppler Probe (used for the intraoperative and transcutaneous critical evaluation of blood flow)Reference Number: VTI-108660Lot Number: 11786-37683ARTG Number: 146966
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd