Important Product Recall Notice

Posted by Vygon (UK) Ltd on 06-October-2011

Vygon has issued the following product recall notice on Octopus three lumen with anti-reflux valves. It has been identified that, due to a production error, there may be a number of products of batch number 080411AE, which may incorporate an anti-syphon valve instead of an anti-reflux valve.

In the event of a device incorporating an anti-syphon valve and being used for a gravity infusion, the infusion will not reach the patient.

OCTOPUS – 3 x ANTI REFLUX VALVES+CLAMPS

FSCA – Identifier: 1109/26992/00

Type of Action: RECALL

Product Code: 0841361

Lot Number: 080411AE

Action

Identify and quarantine any remaining stock, Contact Vygon (UK) Ltd (using the contact details below) to arrange the return and replacement from a different batch.

Transmission of this Field Safety Notice

This notice needs to be passed on to all recipients of this product within your organisation, in particular, the following:

All departments using IV access devices Intensive Care Units
All Wards A&E Departments
Risk Managers Maternity Units
Health and Safety Managers Anaesthetic Department
Purchasing Managers Theatres
Medical Directors Radiology
Nursing Directors Neonatal Units.

Please maintain awareness of this FSN and resulting action for an appropriate period to ensure effectiveness of the corrective action.

If you have any questions or concerns, please contact:

Technical Support Department
Vygon (UK) Ltd
The Pierre Simonet Building
V Park, Gateway North
Latham Road
Swindon
Wiltshire
SN25 4DL

Phone: (01793) 748800
Fax: (01793) 748899

Vygon (UK) Ltd apologises for any inconvenience this FSN may cause.

This Field Safety Notice has been communicated to the MHRA.

For more information please use the Contact Form