- Locate, quarantine and return all affected product.
- Return acknowledgement document to manufacturer (or complete online form as stated in the Field Safety Notice (FSN)).
All healthcare professional involved in the purchase and use devices
Deadlines for actions
Actions underway: 22 October 2018
Actions complete: 12 November 2018
Medical Device Safety Officers (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
If your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Affected devices with expiry date prior to 31 May 2028:
Red Dragon Court, Unit 2, South Road
Bridgend Industrial Estate
Tel: 01656 333932
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:
- Infection control departments
- Infection control nurses
- Infection prevention and control directors
- Orthopaedic surgeons
- Outpatient clinics
- Outpatient theatre managers
- Outpatient theatre nurses
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
Public Health England
Directors for onward distribution to:
- Collaborating centres
- Consultants in communicable disease control
- Divisional directors
- Heads of department
- Heads of health, safety and quality
- Health protection nurses
- PHE laboratories
- Regional microbiologists
- Risk manager
- Safety officers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/032 or 2018/006/021/701/023
Sara Vincent or Catriona Blake, MHRA
Tel: 020 3080 7169 or 7219
Email: firstname.lastname@example.org or email@example.com
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card https://yellowcard.mhra.gov.uk/
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
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
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
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.
Enquiries in Wales should be addressed to:
Healthcare Quality Division, Welsh Government
Tel: 02920 823 624 / 02920 825 510
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).