Events

Recall of Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen Tubing

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-2017-RN-00649-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00649-1
  • 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
    An internal assessment of product reports by convatec has confirmed that specific high concentration oxygen masks have an issue whereby the tubing has been found to disconnect from the oxygen mask, prior to use or during use, causing a disruption in supply of oxygen.
  • Action
    ConvaTec is requesting that customers quarantine affected product in their inventory. ConvaTec will organise for product returns and credit.

Device

Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration wi...
  • Model / Serial
    Unomedical High Concentration Oxygen MasksNon-Rebreather Oxygen Mask, Adult High Concentration with 2.1 m (7') Oxygen TubingProduct Code: 108MMBatch Numbers: 106253 and 112025Non-Rebreather Oxygen Mask, Paediatric High Concentration with 2.1 m (7') Oxygen TubingProduct Code: 3230MMBatch Number: 13-20ARTG Number: 189280
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd