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a alert imageFebruary 27 2018

Patients using an Aquilon nebuliser should stop doing so immediately, the MHRA has warned. Its medical device alert relates to Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series medical nebulisers manufactured since April 1 2015. 

In an alert issued on February 22, the regulator said that people should stop using the nebulisers and dispose of them, and use an approved alternative make where necessary. It is thought more than 8,000 Aquilon nebulisers affected by the alert are being used currently in the UK.

The alert has been raised because the manufacturer had continued to place the nebulisers on the market, despite the medical devices having had CE mark certification withdrawn. “The affected nebulisers and packaging do have a CE mark placed on them, however this has not been obtained through appropriate regulatory oversight and therefore, their safety cannot be assured,” said the MHRA.

Details of the affected products given in the alert are as follows:

Model Start End
AL1 2015-4152 2015-4782
  2016-5000 2016-5921
  2017-6000 2017-6999
AL7 2015-5478 2015-6999
  2015-4659 2015-4689
  2016-7000 2016-9887
  2017-5000 2017-5995
  2017-2000 2017-3968
H02 2015-2056 2015-2522
  2016-3000 2016-3724
  2017-4000 2017-4698
H51 2015-9795 2015-9868
  2016-9875 2016-9965
  2017-1000 2017-1150

John Wilkinson, MHRA’s Director of Medical Devices, said: “We have been made aware that the manufacturer has continued to sell nebulisers even after their CE certification was withdrawn.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“We are taking action, as a matter of priority, to make sure people are aware the CE mark has been withdrawn and that these devices should not be used and should be disposed of. Patient safety is our highest priority and we urge anyone with questions to speak to a healthcare professional as soon as possible.”

Links:
MHRA announcement
MHRA Medical Device Alert     

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