Events

Recall of Latex Test Lungs and Latex Rebreathing Bags

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-00332-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00332-1
  • 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
    A user suffered an acute allergic reaction after using a dräger latex test lung; the user did not suffer permanent injury. review of this incident identified that the device labels did not have internationally recognised indication of latex material.
  • Action
    Drager is correcting the product labels to include a warning that the device contains latex.

Device

Latex Test Lungs and Latex Rebreathing Bags

Manufacturer

Draeger Medical Australia Pty Ltd