- Identify affected products listed in the manufacturer’s Field Safety Notice (FSN).
- Stop using the devices immediately.
- Follow the instructions in the manufacturer’s FSN to return affected devices.
Deadlines for actions
Actions underway: 21 February 2018
Actions complete: 07 March 2018
||NHS Supply Chain code
Teleflex UK customer service
Tel: 07496 719651
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:
- Adult intensive care units
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Cardiothoracic departments
- Cardiothoracic surgeons
- Coronary care departments
- Coronary care nurses
- General surgeons
- General surgery
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Operating department practitioners
- Paediatric surgeons
- Paediatric surgery, directors of
- Purchasing managers
- Supplies managers
- Theatre managers
- Theatre nurses
- Urological surgeons
- Urology departments
- Hospitals in the independent sector
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/004 or 2017/011/024/228/008.
Jenifer Hannon or Leanne Simpson, MHRA
Tel: 020 3080 6268 / 6807
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS 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
Northern Ireland Adverse Incident Centre (NIAIC)
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
Fax: 0131 314 0722
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,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).