Events

Recall of Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration

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-2017-RN-00755-1
  • Event Risk Class
    Class II
  • 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-00755-1
  • 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 has received multiple reports of tubing detaching from the oxygen masks either prior to use (in the packaging) or during use. the detachment of the tubing would result in loss of oxygen to the patient. an investigation determined the failure was caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector.
  • Action
    Thermo Fisher is advising users to inspect their stocks and quarantine all units from the affected batch numbers. Thermo Fisher will arrange for stock to be recovered and replacement stock, or a credit note, to be issued.

Device

Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med Concentration
  • Model / Serial
    Promed High Concentration Oxygen Masks, Elongated (under chin), Adult Med ConcentrationCatalogue Numbers: PMD06001, PMD06002, PMD06003, PMD06009 and PMD06106Lot Numbers: 100914, 100551, 100550, 100574 and 100581ARTG Number: 216605
  • Manufacturer
    Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Thermo Fisher Scientific Australia Pty Ltd