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MDA/2007/047 - IV solution administration set: models 3101-PNOY, 3101-PVJ and 3101-PN3 manufactured by Arcomedical Infusion Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/047
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 5 June 2007 at 12:00
Ref: MDA/2007/047

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
IV solution administration set: models 3101-PNOY, 3101-PVJ and 3101-PN3 manufactured by Arcomedical Infusion Ltd.

>Page 2

Problem:
Two manufacturing faults have resulted in either:

  • the delivery accuracy rate being outside the specification when using models 3101-PNOY and 3101-PVJ with volumetric pumps, or
  • free-flow when using model 3101-PN3 with volumetric pumps.

Therefore the manufacturer is recalling specific lots.

>Page 2

Action by:
Medical, nursing and procurement staff who have responsibility for accessing and purchasing IV devices.		  

Action:

  • Identify and quarantine affected stock. The affected models, lots and NHS Supply Chain codes are listed overleaf.
  • Contact the manufacturer to organise the return and replacement of affected stock.
  

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): 26 June 2007
Deadline (action complete): 17 July 2007


Page last modified: 07 February 2008