- 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.
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.
The SAM XT devices affected by the recall can be distinguished from non-affected devices by 3 methods.
- The absence of a Box X stitch on the IFU
- The absence of a Box X Stitch on the device
- 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.
SAM Medical Products
27350 SW 95th Ave
Water-Jel Europe LLP
3&4 The Mead Business Centre
Tel:+44 1992 583222
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
- Paramedic staff
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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/022 or 2018/005/003/601/011.
Sophie Clewlow or Sara Vincent, MHRA
Tel: 020 3080 6871 or 020 3080 7169
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
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
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).