- Identify affected devices (see below) and stop using them.
- Quarantine and destroy all affected devices in stock.
- Contact Intersurgical to acknowledge receipt of the Field Safety Notice (dated 28 March 2017) even if you don’t have affected devices left in stock.
All healthcare professionals involved in the use of these devices.
Deadlines for actions
Actions underway: 16 June 2017
Actions complete: 23 June 2017
The following models and LOT numbers are affected:
- Solus Flexible, small paediatric, wire-reinforced laryngeal mask airway 2
- Solus Flexible, large paediatric, wire-reinforced laryngeal mask airway 2.5
- Solus Flexible, small adult, wire-reinforced laryngeal mask airway 3
- Solus Flexible, medium adult, wire-reinforced laryngeal mask airway 4
- Solus Flexible, large adult, wire-reinforced laryngeal mask airway 5
LOT numbers: from 31310139 to 31703855 inclusive.
||NHS Supply Chain Codes
||Scottish NDC Codes
||NDC SKU 057290
||NDC SKU 057306
Telephone: 0118 9656 300
Fax: 0118 9656 356
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E departments
- Adult intensive care units
- Ambulance services directors
- Ambulance staff
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Community hospitals
- Day surgery units
- EBME departments
- Equipment stores
- General surgical units, directors of
- Health and safety managers
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Medical directors
- Paediatric intensive care units
- Resuscitation officers and trainers
- Risk managers
- Theatre managers
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- Independent treatment centres
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/2017/015 or 2017/003/028/299/021.
Suleman Hussain or Emma Rooke, MHRA
Tel: 020 3080 6956 or 020 3080 6609
Email: firstname.lastname@example.org or email@example.com
MHRA Devices Clinical Team
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
Fax: 028 9052 3900
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).