Events

Recall of Vygon Umbilical Catheters

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia 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-01019-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-08-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01019-1
  • 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 vygon has identified a non-systematic wrong marking on specific vygon umbilical catheters. the first mark from the distal tip may be at 5.5cm instead of 4cm.
  • Action
    Device Technologies is requesting customers: 1.Ensure all relevant personnel at their facility are fully informed of this notice, including medical staff who use Vygon Umbilical Catheters; 2.Quarantine all affected stocks remaining at their premises; and 3.Complete and return the supplied Reply Fax Form to acknowledge receipt of the notice and quantity of affected stock.

Device

Vygon Umbilical Catheters
  • Model / Serial
    Vygon Umbilical CathetersProduct Code: VY-270.03 Batch Numbers: 241116FR, 281116FR, 071216FR, 151216FR, 211216FR, 050117FR, 230217FR, 280217FR, 060117FR and 150217FR ARTG Number: 141061
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd