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MDA/2007/061 - Oxygen humidifier: - Hudson RCI® large volume nebuliser, product code 41770, NHS Supply Chain Code FDE 069

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/061
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 August 2007 at 14:30
Ref: MDA/2007/061


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Oxygen humidifier: - Hudson RCI® large volume nebuliser, product code 41770, NHS Supply Chain Code FDE 069. Lot numbers consisting of 10 numbers beginning: 50069/….., 52069/….., 01079/….., 06079/….., 16079/….., 17079/….. 17079R/…., 18079/….. Manufactured by Teleflex Medical.

>Page 2

Problem:
There is the potential for lower than required oxygen concentration to be delivered due to a manufacturing fault. The manufacturer has recalled the above devices. (See Appendix - in pdf only).		  
Action by:
Medical and nursing staff. Supplies departments.		  

Action:

  • Ensure that all relevant staff are aware of this recall.
  • Identify and quarantine affected stock.
  • Contact the manufacturer to organise the return and replacement of affected 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

Appendix:
Manufacturers recall letter and faxback form (in pdf only).

>Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 28 August 2007
Deadline (action complete): 11 September 2007


Page last modified: 07 February 2008