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MDA/2008/073 - Solus laryngeal mask airway manufactured by Intersurgical

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/073
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: 08 October 2008 at 14:30
Ref: MDA/2008/073

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Solus laryngeal mask airway manufactured by Intersurgical.
Product code: 8002, lot no: 380009, NHS Supply Chain Number FDD749.

>Page 2

Problem:
Possibility of moulding defects in the device’s 15mm connector, which could cause it to break off during use.		  
Action by:
All staff who use, supply or purchase this device.		  

Action:

  • Identify and quarantine those devices affected by this Alert.
  • Contact Intersurgical for replacements of affected devices. 
 

Distributed to:

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

>Pages 2-3

Appendix:
Manufacturer’s Urgent Field Safety Notice (in pdf only).

>Pages 4-5



Action deadlines for the Central Alerting System (CAS)
Deadline (action underway): 29 October 2008
Deadline (action complete): 19 November 2008


Page last modified: 08 October 2008