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MDA/2006/026 - Universal Hospital Supplies Guedel airways - Lot numbers beginning with the year of manufacture e.g. 2005 B 11. (Lot numbers with the prefix WO are not affected)

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Document details:

Type: Medical Device Alert
Series No: MDA/2006/026
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 03 May 2006 at 12:00
Ref: MDA/2006/026


 

Tick mark
Immediate action
 
Action
 
Update
 
Information request

 

Device:
Universal Hospital Supplies Guedel airways - Lot numbers beginning with the year of manufacturer e.g. 2005 B 11.
(Lot numbers with the prefix WO are not affected.)
Size 1 - Ref: UN 38/1
Size 2 - Ref: UN 38/2
Size 3 - Ref: UN 38/3
Size 4 - Ref: UN 38/4

 >Page 2

Problem:
Due to manufacturing problems the Guedel airways may be split around the bite block allowing the coloured insert to become dislodged from the main body of the airway (figure 1, page 2). The supplier is recalling affected lot numbers of Universal Guedel Airways sizes 1, 2, 3 and 4. See appendix for supplier's recall notice (see pdf document).		  
Action by:
Anaesthetists, operating department practitioners, anaesthetic nurses, adult and paediatric intensive care unit (ICU) staff, accident and emergency unit (A&E) staff, ambulance staff and resuscitation officers.		  

Action:

  • Remove this product from use and quarantine.
  • Arrange collection and refund of recalled stock via usual distribution channels (see appendix in pdf).
  • Be aware that comparable product is available from other manufacturers. If alternatives are not immediately available, ensure there are no splits or occlusion before use and that staff are aware of the possible failures.
  

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*
Social services in England - Directors*

* 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 CSCI and Healthcare Commission.		  

 >Page 3

Appendix: Universal Hospital Supplies recall notice (see pdf document).  

 >Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 17 May 2006
Deadline (action complete): 26 May 2006


Page last modified: 07 February 2008