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MDA/2007/072 - Endotracheal tubes: Microcuff paediatric endotracheal tubes manufactured by Kimberly-Clark NV/SA

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/072
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: 11 September 2007 at 14:30
Ref: MDA/2007/072


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Endotracheal tubes: Microcuff paediatric endotracheal tubes manufactured by Kimberly-Clark NV/SA.

>Page 2

Problem:
The device may kink during use, which may impede or prevent ventilation.		  
Action by:
Anaesthetists, intensive care specialists, paediatrics and neonatology medical and nursing staff.		  

Action:

  • Identify and quarantine stock from all batches of affected product range (see overleaf for product list).
  • The manufacturer is recalling all potentially affected devices. See manufacturer recall letter in the appendix (in pdf only).
  • Contact the manufacturer to arrange the return of affected stock and reimbursement for
    returned product.
  

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.

>Pages 2-3

Appendix:
Manufacturer’s field safety notice (in pdf only).

>Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 09 October 2007
Deadline (action complete): 06 November 2007


Page last modified: 07 February 2008