Events

Recall of Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + Nebuliser 210cm T/Mouth10/50Opti-Mist + Nebuliser 210cm admask 10/50Opti-Mist + Nebuliser Ped Kit (5X10) Opti-Mist + CS Fits-A 210cm(10/20)Opti-Mist Plus Nebuliser Only (10/50) Opti-Mist CL Nebuliser Kit (50)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Thermo Fisher Scientific 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-01184-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01184-1
  • 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
    Specific batches of nebuliser mask products are not meeting specification. an error in the manufacturing of a component (jet orifice) resulted in this component being unable to produce atomisation or misting of supplied medication, saline or water contained in the nebuliser unit. no or poor misting would impact the delivery of aerosolised liquids to the patient, which has the potential to result in harm if used with this defect.
  • Action
    Thermo Fisher is advising users to inspect and quarantine any affected stock for return to Thermo Fisher. This action has been closed-out on 26/08/2016.

Device

Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + N...
  • Model / Serial
    Opti-Mist Nebuliser / Nebuliser Mask ProductsOpti-Mist Nebuliser Kit 210cm Tmouth 50Opti-Mist + Nebuliser 210cm T/Mouth10/50Opti-Mist + Nebuliser 210cm admask 10/50Opti-Mist + Nebuliser Ped Kit (5X10) Opti-Mist + CS Fits-A 210cm(10/20)Opti-Mist Plus Nebuliser Only (10/50) Opti-Mist CL Nebuliser Kit (50)Product Codes: PMD02600, PMD02601, PMD02602, PMD02603, PMD02604, PMD02605, PMD02606Multiple Lot NumbersARTG Number: 214820
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd