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MDA/2007/004 - Vygon (UK) Ltd paediatric IV bacterial filter with extension line

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/004
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: 16 January 2007 at 14:30
Ref: MDA/2007/004

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Vygon (UK) Ltd paediatric IV bacterial filter with extension line.
Product code: 0807.205 (NHS Supply Chain code: FTC215).
Batch numbers: 050805AA, 020905AA, 160905AA, 180205AA, 030605AA and 180705AA.		  
Problem:
Cracking of the green hub on the filter has resulted in leakage. The manufacturer is recalling specific batches.		  
Action by:
Theatre managers; nursing/medical staff working in paediatric/neonatal units.		  

Action:

  • Identify and quarantine stock from affected batches.
  • Contact the manufacturer (Tel: 01285 886 016) to organise return and replacement of stock.
  

Distributed to:

NHS trusts in England - Chief Executives*
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 Healthcare Commission.

>Page 2



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 16 February 2007
Deadline (action complete): 16 March 2007


Page last modified: 07 February 2008