Safety warning concerning Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series nebuliser
Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series nebulisers" (model numbers AL1, AL7, H02, H51) of the manufacturer "AFP Medical" with date of manufacture since 01 April 2015.
The BASG has been informed by the Medicines & Healthcare products Regulatory Agency (MHRA) in the United Kingdom that the above products have been unlawfully placed on the market. The manufacturer has not provided sufficient evidence that the products comply with the legal requirements.
The safety of these medical devices is not proven. Based on the information currently available, the Federal Office warns all potential users against further use of these medical devices. Affected patients are recommended to use alternative products.
If necessary, please contact the attending physician or your pharmacist.
Aquilon Pro series Vernebler
Modellnummern AL1, AL7, H02, H51