Events

Recall of Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Draeger Medical 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-2014-RN-00567-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00567-1
  • 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
    Drager has become aware of cases where prior to the use of the disposable ventstar oxylog 2000 ventilation hoses, adhesive residue the size of a finger nail was found loose in the hose or the packaging around the hose; had teh hose been used with the residue in place it may have entered the patient's lungs.
  • Action
    Draeger is advising their customers to not use the hose system from the affected batches and to contact customer service to arrange for recovery and replacement.

Device

Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Venti...
  • Model / Serial
    Disposable Ventstar 180cm Circuit (used in connection with the Drager Oxylog 2000 Transport Ventilator)Product Description: Packaging Box SetPart Number: 2M86841Batch Numbers: 330384.001 - 331661.002Product Description: Hose PackagingPart Number: 2M86791Batch Numbers: 330384.001 - 331661.002ARTG Number: 131796
  • Manufacturer
    Draeger Medical Australia Pty Ltd

Manufacturer

Draeger Medical Australia Pty Ltd