Events

Recall of OxyCap Adult CO2 Sampling Oxygen Mask

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Proact Medical Systems (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-2013-RN-00356-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-04-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00356-1
  • 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
    It has been identified that the tubing was not fitted correctly to the mask during production. this may result in malfunctioning during use, whereby, if the tubing and masks connected by the user is not firm enough, the tubing may come off during usage.
  • Action
    Device Technologies / Proact Medical Systems is recalling the affected masks.

Device

OxyCap Adult CO2 Sampling Oxygen Mask

Manufacturer

Proact Medical Systems (Australia) Pty Ltd