Medical Device Alert: Sutures manufactured by ETHICON (MDA/2011/022)

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/022 or 2010/012/029/601/002.

Technical aspects
Allan Hidderley or Ian Smith
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7172/7306
Fax: 020 8754 3965
Email: allan.hidderley@mhra.gsi.gov.uk or ian.smith@mhra.gsi.gov.uk 

Clinical aspects
Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ
Tel: 020 3080 7126
Fax: 020 8754 3965
Email: nicola.lennard@mhra.gsi.gov.u

How to report adverse incidents
Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the Central Alerting System website (external link).

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Enquiries in Wales should be addressed to:

Dr Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922

Email: Haz-Aic@wales.gsi.gov.uk

The unit pack in the affected products may not have a complete seal and so the contents may not be sterile.

There is a risk of infection if non-sterile sutures are used.

Follow the actions set out in ETHICON’s Field Safety Notice dated 29 December 2010.

These are:

• Do not use affected products
• Locate and quarantine affected products
• Return affected products to your distributor or ETHICON along with their ‘Recall Confirmation Form’.

This MDA has been sent to:

• NHS trusts in England (Chief Executives)
• Care Quality Commission (CQC) (Headquarters) for information
• HSC trusts in Northern Ireland (Chief Executives)
• NHS boards in Scotland (Equipment Co-ordinators)
• NHS boards and trusts in Wales (Chief Executives)
• Primary care trusts in England (Chief Executives)

Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

• All clinical departments
• All staff
• All wards
• A & E departments
• Ambulance staff
• Clinical governance leads
• Day surgery units
• Intensive care units
• Maternity units
• Obstetric theatres
• Purchasing managers
• Sterile services managers
• Supplies managers
• Surgeons
• Theatres
• Theatre nurses

Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

• Community hospitals
• Community midwives
• Community nurses
• General practitioners
• General practitioners – out of hours emergency centres
• Minor injury units
• NHS walk-in centres
• Practice managers
• Practice nurses
• Walk-in centres

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

• Clinics
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Nursing agencies
• Private medical practitioners

Ethicon Products Division, J&J Medical Ltd
Mr Mark Struthers,QA Manager
Simpson Parkway
Kirkton Campus
Livingston
West Lothian
EH54 7AT

Tel: 01506 5944500
Email: Complaints@ethgb.JNJ.com

If you have any comments or feedback on this Medical Device Alert, please email us at: dts@mhra.gsi.gov.uk