Events

Recall of Corpuls3 CO2 Disposable Naso-oral Adaptor Capone

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-00535-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-05-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00535-1
  • 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
    There have been two local reports of the mouth piece part of the device being dislodged into the throats of patients. the mouth piece is manufactured to be manually removed if clinically necessary. the results of an investigation revealed that it occurred due to a high level of patient agitation. there is a potential risk of asphyxiation if this problem occurs.
  • Action
    Device Technologies is updating the IFU (Instructions for Use) to state that it should only be used on patients who can tolerate the adapter and that the oral breath collector may come loose under extreme conditions and could be aspirated. Users are also requested to retain a copy of their recall letter with the IFU of the affected device.

Device

Corpuls3 CO2 Disposable Naso-oral Adaptor Capone
  • Model / Serial
    Corpuls3 CO2 Disposable Naso-oral Adaptor CaponeProduct Code: CP-4234.21All Lot NumbersARTG Number: 281369 and 192745
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd