Events

Recall of Laryngoscope Handles (LED) and Laryngoscope Fibre Optic Blades; Laryngoscope Handles (LED); Laryngoscope Fibre Optic Blades

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Oliver Medical 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-2012-RN-00617-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-07-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00617-3
  • 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 ‘cold soak disinfection’ section of the instructions for use requires the inclusion of a rinse step which is necessary post-disinfection with gluteraldehyde / cidex.
  • Action
    IFU update

Device

Laryngoscope Handles (LED) and Laryngoscope Fibre Optic Blades; Laryngoscope Handles (LED); Laryn...
  • Model / Serial
    Laryngoscope Handles (LED) (Item No 08-100) and Laryngoscope Fibre Optic Blades (Item No 08-101)Laryngoscope Handles (LED) (Item No 08-100)ARTG number: 184682Laryngoscope Fibre Optic Blades (Item No 08-101)ARTG number: 184681All batches
  • Manufacturer
    Oliver Medical Pty Ltd

Manufacturer

Oliver Medical Pty Ltd