Events

Recall of Single Limb Circuit for Pneupac Ventilators, with PEEP Valve

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smiths Medical Australasia 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-00047-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00047-1
  • 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
    Certain single limb circuits were labelled as “mr conditional” but contained peep valves that should have been labelled as “mr unsafe”.If the affected products are used in an mr environment, there is a potential for the peep valve to become dislodged during the mri procedure. the effect of a reduction of peep pressure could be a reduction in oxygen saturation of the blood which would be detectable by clinical observation of signs and symptoms and through oximetry. also there is the potential for the affected products to create artifacts in the mri scan; however, these artifacts would be highly detectable by the clinician reading the mri.
  • Action
    Facilities that use the Single Limb Circuit in the MRI suite are requested to quarantine the affected devices. A Smiths Medical representative will arrange for the exchange of unused affected product. This action has been closed-out on 08/08/2016.

Device

Single Limb Circuit for Pneupac Ventilators, with PEEP Valve
  • Model / Serial
    Single Limb Circuit for Pneupac Ventilators, with PEEP ValveOrder code:100/905/301 Batch numbers: 121105, 130128, 130225, 130408, 130624, 131209, 140217, 140407, 140428 & 140616 Order code:100/905/302Batch numbers: 120229, 120326, 120402, 120507, 120716, 120820, 130318, 130520, 130819, 131007, 131125, 131216, 140526, 140707 & 140714 ARTG number: 109570
  • Manufacturer
    Smiths Medical Australasia Pty Ltd

Manufacturer

Smiths Medical Australasia Pty Ltd