Events

Recall of Vygon SA – Y connector code 884.08(tubing connector)

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-2015-RN-00634-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00634-1
  • 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
    Vygon has identified a manufacturing defect, which could result in blockage of the y-connector. this obstruction cannot be visually detected by the end user before use.
  • Action
    Device Technologies are requesting users read this notice in full and distribute to all relevant personnel and to inspect their inventory and isolate any of Vygon Y Connector with product code VY-884.08 and lot number 100315EG and to complete the attached Reply Fax Form. This action has been closed-out on 31/08/2016.

Device

Vygon SA – Y connector code 884.08(tubing connector)

Manufacturer

Device Technologies Australia Pty Ltd