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MDA/2006/061 - Blood administration set: volumed blood set, manufactured by Sendal SA and distributed by Arcomedical Infusion Ltd

Document details:

Type: Medical Device Alert
Series No: MDA/2006/061
Audience: Healtcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 24 October 2006 at 11:00
Ref: MDA/2006/061
 
Immediate action
Tick mark
Action
 
Update
Tick mark
Information request


Device:
Blood administration set: volumed blood set
manufactured by Sendal SA and distributed by Arcomedical Infusion Ltd.
Model number: 3101-TJ, batch number: C6766.
NHS Supply Chain code: FSB123.
 
Problem:
Risk of blood leakage due to a crack at the Y-site on a single batch of the blood set. This alert is to reinforce the recall undertaken by NHS Supply Chain (previously NHS Logistics) recall reference number 22 and to establish if there have been further incidents.
 
Action by:
All medical and nursing staff, theatre managers and anaesthetists.
 

Action:

  • Check for and isolate any of the affected batch in stock.
  • Contact your local NHS Supply Chain customer service department to arrange for return and replacement of any of the above product.
  • Report any incidents involving this device to the MHRA.
 

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters

* via CE Bulletin

>Page 2

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

>Page 2



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 14 November 2006
Deadline (action complete): 05 December 2006


Page last modified: 07 February 2008