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MDA/2007/094 - Robertshaw endobronchial tubes (rubber, disposable), all sizes. Manufactured by Pheonix Medical, a P3 Medical Ltd company

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/094
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 06 December 2007 at 13:30
Ref: MDA/2007/094


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Robertshaw endobronchial tubes (rubber, disposable), all sizes.
Manufactured by Pheonix Medical, a P3 Medical Ltd company.

>Page 2

Problem:
There is a risk of cuff deflation due to a manufacturing design change. Affected product codes and batch numbers are listed overleaf. The manufacturer has now reverted to the original design.

P3 are not able to provide immediate replacement of all affected stock and are not aware of any alternative equivalent devices manufactured from natural rubber.

>Page 2

Action by:
Anaesthetists, operating department practitioners and anaesthetic nurses.		  

Action:

  • Check stocks for affected product (details overleaf).
  • If you need to use the affected product, follow the supplementary instructions for use contained in the manufacturer’s customer letter.
  

Distributed to:

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

* 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 customer letter (in pdf only).		  >Pages 4-6


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 13 December 2007
Deadline (action complete): 20 December 2007


Page last modified: 07 February 2008