Events

Recall of Allersearch Economist Forte Nebuliser (non heated nebuliser)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ebos Group Pty Limited.

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-2012-RN-00764-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00764-3
  • 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 is recongnised that there is an issue with the economist forte and the fit to the unit with the supplied power cord accessory. in some cases, the power cord moulding is too large to fit into the unit. it is necessary to state that there is no safety issue with the unit, other than the possibility of the device not working due to lack of power supply.
  • Action
    The sponsor is asking pharmacies to return all affected stock to their wholesaler. The sponsor is asking all wholesalers to quarantine affected stock for return.

Device

Allersearch Economist Forte Nebuliser (non heated nebuliser)
  • Model / Serial
    Allersearch Economist Forte Nebuliser (non heated nebuliser)Catalogue Number: AE650-040Batch Numbers: 11AD12 and 11AD12AARTG Number: 98386
  • Manufacturer
    Ebos Group Pty Limited

Manufacturer

Ebos Group Pty Limited