Events

Safety Alert Or Field Safety Notices for Aquilon series of nebulisers

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by AFP Medical.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Date
    2018-02-22
  • Event Date Posted
    2018-02-22
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/aquilon-series-of-nebulisers-ce-mark-withdrawn-and-supply-ceased
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
    Following withdrawal of the CE mark for the Aquilon series of nebulisers, the manufacturer (AFP Medical) has continued to place the nebulisers on the market.The nebuliser and packaging have a CE mark but this has not been obtained through appropriate regulatory oversight.
  • Reason
    Manufactured by afp medical – do not use affected nebulisers as they have been manufactured to unknown standards and their safety cannot be verified (mda/2018/008).
  • Action
    Identify affected devices from the list below. Identify patients and relevant healthcare professionals and advise them to: stop using and dispose of the nebulisers use an alternative nebuliser where available Patients who have any concerns should contact their GP or other healthcare professionalAction by:All medical, nursing and technical staff involved in the use and maintenance of these devices.

Device

Aquilon series of nebulisers
  • Model / Serial
  • Product Description
    Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series manufactured since 01 April 2015 are affected.
  • Manufacturer
    AFP Medical

Manufacturer

AFP Medical
  • Source
    MHRA