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MDA/2007/053 - IV extension lines: model 6222 range of V-Green narrow bore extension lines manufactured by Vygon (UK) Ltd

Document details:

Type: Medical Device Alert
Series No: MDA/2007/053
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 13 June 2007 at 14:00
Ref: MDA/2007/053


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
IV extension lines: model 6222 range of V Green narrow bore extension lines manufactured by Vygon (UK) Ltd.

>Page 2

Problem:
There is a potential for the female connector of the line to crack when used to deliver propofol (an intravenous anaesthetic agent).  This may result in leakage of this drug and failure to induce and maintain general anaesthesia.

The manufacturer has initiated a recall of specific batch numbers irrespective of the drugs they are being used with.

 

>Page 2

Action by:
Anaesthetists, operating department practitioners, theatre managers, anaesthetic nurses and supplies departments.
 

Action:

  • Identify and quarantine affected devices.  The batch numbers are listed overleaf.
  • If propofol is not used in your department, the affected devices should still be quarantined.
  • Contact the manufacturer to organise return and appropriate alternatives to affected stock.  Contact details are provided overleaf.

 

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for CSCI and Healthcare Commission.

>Pages 2-3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 13 July 2007
Deadline (action complete): 13 August 2007


Page last modified: 13 June 2007