Recall of specific lots of RUSCH sensor (series 400) silicone and non-sterile rectal/ pharyngeal temperature sensors

Manufactured by Teleflex – risk of misdiagnosis and delivery of inappropriate treatment as sensors may give an inaccurate temperature reading.

Action

  1. Identify affected products listed in the manufacturer’s Field Safety Notice (FSN).
  2. Stop using the devices immediately.
  3. Follow the instructions in the manufacturer’s FSN to return affected devices.

Action by

  • Healthcare professionals

Deadlines for actions

Actions underway: 21 February 2018

Actions complete: 07 March 2018

Device details

Teleflex code NHS Supply Chain code GS1/UDI
179361-000120 FUS029 24026700000000
179361-000140 FUS030 24026700000000
179361-000160 FUS031 24026700000000
179361-000180 FUS032 24026700000000
179361-000180 FUS032 24026700000000
179360-000120 n/a 24026700000000
179360-000140 n/a 24026700000000
179360-000160 n/a 24026700000000
179360-000180 n/a 24026700000000
1016 n/a 24026700000000

Manufacturer contacts

Teleflex UK customer service
Tel: 07496 719651
Email: <orders.uk@teleflex.com>

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:

  • Adult intensive care units
  • Anaesthetic medical staff
  • Anaesthetic nursing staff
  • Anaesthetists
  • 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
  • Theatres
  • Urological surgeons
  • Urology departments

Independent distribution

  • Hospitals in the independent sector

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2018/004 or 2017/011/024/228/008.

Technical aspects

Jenifer Hannon or Leanne Simpson, MHRA

Tel: 020 3080 6268 / 6807

jenifer.hannon@mhra.gov.uk leanne.simpson@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA

Tel: 020 3080 7274

dct@mhra.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

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

Fax: 0131 314 0722

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 and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2018/004

Published 14 February 2018