Aquilon series of nebulisers – CE mark withdrawn and supply ceased
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 professional
Action by:
- All medical, nursing and technical staff involved in the use and maintenance of these devices.
Deadlines for actions:
- Actions underway: 15 March 2018
- Actions complete: 05 April 2018
Device Details
Aquilon2, Aquilon, Aquilon+ and Aquilon Pro series manufactured since 01 April 2015 are affected.
Detailed list of models and manufacturing dates of these devices:
| 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 |
Problem
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.
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- A&E departments
- A&E directors
- A&E nurses
- Adult intensive care units
- All departments
- All staff
- All wards
- Ambulance services directors
- Ambulance staff
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Anaesthetists
- Biomedical engineering staff
- Biomedical science departments
- Cardiologists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Clinical governance leads
- Community children’s nurses
- Community defibrillation officers
- Community hospitals
- Community nurses
- Coronary care departments
- Coronary care nurses
- Day surgery units
- District nurses
- EBME departments
- Endocrinology
- ENT departments
- ENT medical staff
- Equipment stores
- Equipment libraries and stores
- Fracture clinics
- Gastroenterology departments
- General surgeons
- General surgery
- General surgical units, directors of
- Gynaecology departments
- Haematologists
- Haemodialysis nurses
- Haemodialysis units
- Health and safety managers
- Health visitors
- Hospital at home units
- Hospital pharmacies
- In-house maintenance staff
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Maintenance staff
- Minor injury units
- Maternity units
- Maxillofacial departments
- Medical directors
- Medical libraries
- Medical oncologists
- Medical oncology, directors of
- Medical physics departments
- Midwifery staff
- NHS walk-in centres
- Nursing executive directors
- Obstetricians
- Obstetrics and gynaecology departments
- Obstetrics departments
- Obstetrics nurses
- Occupational health departments
- Occupational therapists
- Oncology nurse specialists
- Operating department practitioners
- Oral surgeons
- Orthopaedic surgeons
- Outpatient clinics
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric oncologists
- Paediatric surgeons
- Paediatric surgery, directors of
- Paediatric wards
- Paediatricians
- Paediatrics departments
- Palliative care teams
- Paramedics
- Patient transport managers
- Peritoneal dialysis units
- Pharmacists
- Physiotherapists
- Purchasing managers
- Resuscitation officers and trainers
- Risk managers
- School nurses
- Staff supporting patients receiving haemodialysis at home
- Supplies managers
- Theatre managers
- Theatre nurses
- Theatres
- Urology departments
- Virologists
- Walk-in centres
Social services
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- In-house domiciliary care providers (personal care services in the home)
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Clinics
- Hospices
- Hospitals in the independent sector
- Independent treatment centres
- Nursing agencies
- Private medical practitioners
Establishments registered with OFSTED
- Children’s services
- Educational establishments with beds for children
- Residential special schools
Please note:
CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/008 or 2018/001/016/291/008.
Technical aspects
Enitan Taiwo or Emma Rooke, MHRA
Tel: 020 3080 7122 / 6609
Email: enitan.taiwo@mhra.gov.uk or emma.rooke@mhra.gov.uk
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: dct@mhra.gov.uk
Reporting adverse incidents in England
Through Yellow Card
Northern Ireland
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website .
Alerts in Northern Ireland are distributed via the NICAS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group, Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Email: niaic@health-ni.gov.uk
https://www.health-ni.gov.uk/niaic
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Scotland
Enquiries and adverse incident reports in Scotland should be addressed to: Incident Reporting and Investigation Centre, Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
Email: nss.iric@nhs.net
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Wales
Enquiries in Wales should be addressed to:
Healthcare Quality Division, Welsh Government
Tel: 02920 823 624 / 02920 825 510
Email: Haz-Aic@wales.gsi.gov.uk
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card https://yellowcard.mhra.gov.uk/ and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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MHRA is a centre of the Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health © Crown Copyright 2018 Addressees may take copies for distribution within their own organisations