Events

Recall of Harris Oxygen Flowmeter

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by HGEA 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-00266-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00266-1
  • 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
    Fisher & paykel healthcare pty ltd is issuing this recall for product correction on behalf of the harris products group as there have been two reports of confusion due to mislabelled measurement lines on the model 86630lox flowmeter. the measurement lines are labelled for arco2 gas and not oxygen gas. there have been no reports of injury to date, however there is potential to set up an incorrect flow of oxygen or air gas to a patient.Note: even though there have been no reports involving the air flow meter, it is being included in this recall as it also uses an arco2 labelled tube.
  • Action
    Harris Products Group is supplying the correction labels to all affected customers. This label is to be affixed to the flow meter to correctly read the flow of Oxygen or Air gas.

Device

Harris Oxygen Flowmeter
  • Model / Serial
    Harris Oxygen FlowmeterModel Numbers: 86630LOX and 86630LAIR (labelled as “Model 866”)All Lot Numbers ARTG No. 140296
  • Manufacturer
    HGEA Pty Ltd

Manufacturer

HGEA Pty Ltd