Events

Recall of Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by ConvaTec 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-01155-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01155-1
  • 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
    Convatec have determined that 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. therefore the nebuliser mask will not deliver the expected therapy to the patient.
  • Action
    The sponsor ConvaTec is advising users to inspect stock and quarantine the affected units prior to their return to the sponsor/distributor. This action has been closed-out on 26/08/2016.

Device

Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) int
  • Model / Serial
    Nebulisers / Nebuliser Mask ProductsUno multi-angle nebuliser (50) intProduct Code: 1638-00Uno Multi-angle nebuliser MP T-Piece (50) intProduct Code: 1638-01Uno Aero Mask AD MA Nebuliser 210cm (50) intProduct Code: 1651-21Uno Aero Mask Child Multi-Angle Nebuliser 210cm (1x50) intProduct Code: 1654-21Multiple Lot Numbers affectedARTG Number:160226
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd