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MDA/2008/074 - Blood administration set. Volumed set manufactured by Sendal S.A. Distributed exclusively in the UK by Arcomedical Infusion Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/074
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 13 October 2008 at 14:30
Ref: MDA/2008/074

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Blood administration set. Volumed set manufactured by Sendal S.A. Distributed exclusively in the UK by Arcomedical Infusion Ltd.
Product code 3101TJ, batch TC1033.
NHS Supply Chain Code FSB123.		  
Problem:
The set cannot be primed beyond the drip chamber due to a manufacturing error. This renders the set unusable, causing a delay in treatment.
This alert is to reinforce the recall undertaken by NHS Supply Chain (NHSSC RECALL 18).		  
Action by:
All medical and nursing staff.		  

Action:

  • Identify and isolate affected devices.
  • Do not use affected devices.
  • Return affected devices to the distributor as directed in the recall notice (see appendix - in pdf only).
  

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*
NHS Boards in Scotland - Chief Executives

* via CE Bulletin

>Page 2

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

>Pages 2-3

Appendix:
Manufacturer's recall notice (in pdf only).

>Pages 4-5



Action deadlines for the Central Alerting System (CAS)
Deadline (action underway): 23 October 2008
Deadline (action complete): 03 November 2008


Page last modified: 13 October 2008