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MDA/2007/028 - Reusable flexible laryngeal mask airway size 2.5 supplied by Intavent Orthofix Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/028
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 22 March 2007 at 10:30
Ref: MDA/2007/028

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Reusable flexible laryngeal mask airway size 2.5 supplied by Intavent Orthofix Ltd.
Model codes: 7125R and 7125DR.
See appendix for serial numbers of affected devices (in pdf only).		  

>Page 2

Problem:
Risk of the tube kinking in the proximity of the connector, which could lead to the obstruction of airflow to the patient. The supplier has initiated a recall of specific serial numbers and has been unable to account for the serial numbers listed in the appendix.		  

>Page 2

Action by:
Anaesthetists, operating department practitioners, anaesthetic nurses, accident and emergency unit (A&E) staff, ambulance staff, sterile services department staff, supplies staff and all staff using anaesthetic equipment and associated devices.		  

Action:

  • Identify and quarantine affected devices (see appendix for serial numbers of devices that have not been accounted for).
  • Contact the manufacturer to arrange 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 supplier contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.		  

 >Page 3

Appendix:
List of serial numbers of affected devices that have not been accounted for (in pdf only).		  

 >Page 4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 29 March 2007
Deadline (action complete): 23 April 2007


Page last modified: 07 February 2008