SAM XT Extremity Tourniquet - Recall due to the risk of tourniquet failing in use

Manufactured by SAM Medical Products - An error in the manual sewing operations of devices manufactured from March 2017 to April 2018 may cause the seam holding the buckle to the belt to fail.

Action

  • Refer to the manufacturer’s FSN for a list of affected lot numbers.
  • Identify and quarantine affected devices.
  • Return any affected devices and the completed recall response form to the distributor.

Action by

Healthcare Professionals.

Deadlines for actions

Actions underway: 19 July 2018

Actions complete: 02 August 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.

Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.

Device details

The SAM XT devices affected by the recall can be distinguished from non-affected devices by 3 methods.

  1. The absence of a Box X stitch on the IFU
  2. The absence of a Box X Stitch on the device
  3. Any Lot Number from XT1711 to XT1811

An affected tourniquet will NOT have the box-stitch icon on the device or on the upper right of the Instructions For Use (IFU) insert.

Manufacturer contacts

SAM Medical Products
27350 SW 95th Ave
Suite 3038
Wilsonville
OR
97070
US
Email: jeff.lipps@sammedical.com

Tel: 001-503-783-6915

jeff.lipps@sammedical.com

Water-Jel Europe LLP
3&4 The Mead Business Centre
Mead Lane,
Hertford
SG13 7BJ
Email: terry.obrien@waterjel.net

Tel:+44 1992 583222

terry.obrien@waterjel.net

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
  • Ambulance services directors
  • Ambulance staff
  • Paramedics
  • Paramedic staff

Independent distribution

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/2018/022 or 2018/005/003/601/011.

Technical aspects

Sophie Clewlow or Sara Vincent, MHRA

Tel: 020 3080 6871 or 020 3080 7169

Email: sophie.clewlow@mhra.gov.uk or sara.vincent@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

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

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

SAM XT Extremity Tourniquet - Recall due to the risk of tourniquet failing in use

Published 5 July 2018
Last updated 6 July 2018 + show all updates
  1. Change to one of the three methods of identifying affected devices (point 3), from any device with lot number XT1812 or higher to any lot number from XT1711 to XT1811. Additional sentences above each figure in the PDF added to help identify affected devices.
  2. First published.