Thousands of patients are being urged to immediately stop relying on their life-saving nebuliser because their safety ‘cannot be assured’.
Health officials announced 8,000 of the devices, given to cystic fibrosis patients and used during flare-ups of lung diseases and asthma, have been affected.
Aquilon continued to sell its devices despite having its safety certificate withdrawn in 2015, Government advisors today warned.
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert amid fears the lives of patients relying on them may be in danger.
John Wilkinson, MHRA’s director of medical devices, begged patients to avoid using the devices – typically used in hospitals – and said they should be disposed of.
Health officials today announced 8,000 of the devices, given to cystic fibrosis and COPD patients, have been affected by the dangerous error
He added: ‘We have been made aware that the manufacturer has continued to sell nebulisers even after their CE certification was withdrawn.
‘We cannot guarantee they have been manufactured to an appropriate standard.
‘These devices deliver potential life-saving treatment and it is vital they operate correctly when needed.
‘We are taking action, as a matter of priority, to make sure people are aware the CE mark has been withdrawn and that these devices should not be used and should be disposed of.’
The Medicines and Healthcare products Regulatory Agency (MHRA) issued the alert amid fears the lives of patients relying on them may be in danger
MORE THAN 6,000 ASTHMA INHALERS ARE RECALLED BY GOVERNMENT
Faulty asthma inhalers ‘could put lives at risk’, a charity warned yesterday after a product recall by Government advisors.
The Medicines Healthcare Regulations Agency announced more than 6,000 inhalers pose a threat to sufferers in the UK.
It warned a ‘manufacturing issue’ meant two batches of popular inhalers weren’t delivering the full number of life-saving doses.
Asthma UK urged sufferers to check their inhalers to see if they are affected, to avoid any potentially fatal complications.
In the urgent alert, the MHRA declared the safety of Aquilon2, Aquilon, Aquilon+ and Aquilon Pro nebulisers ‘cannot be assured’.
It revealed the affected nebulisers – manufactured since April 2015 by AFP Medical – and packaging do have a CE mark placed upon them.
However, ‘this has not been obtained through appropriate regulatory oversight’, the MHRA announced in its statement.
A medical device cannot be marketed in Europe without carrying a CE mark, which means the device meets standards, works properly and is safe.
Nebulisers are a life-saving gadget given to patients who are struggling to breathe, which is considered a medical emergency.
It allows patients to breathe in a medicine as a mist through a mask or a mouthpiece, according to the British Lung Foundation.
The MHRA urged patients with concerns to speak to a healthcare professional or GP, who will be able to answer any questions.