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MDA/2008/054 - Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, lot no 499265

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/054
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 6
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 22 July 2008 13:35
Ref: MDA/2008/054

 

 
Immediate action
Tick mark 
Action
 
Update
 
Information request


Device:
Smiths Medical Portex™ Blue Line Ultra tracheostomy kits, lot no. 499265.

> Page 2

Problem:
Blue Line Ultra Suctionaid tracheostomy change kits (product code 100/880/080) from lot 499265 will contain a Blue Line Ultra fenestrated, uncuffed tube. Although this tube will maintain an airway if used, it will reduce ventilation efficiency and will not provide any direct suctioning ability.

Smiths Medical is recalling these devices due to the incorrect labelling (see appendix).

> Page 2 and Appendix

Action by:
Supplies department, operating theatre, A&E, ITU and ENT staff involved in the supply and use of these devices.		  

Action:

  • Identify and quarantine those devices affected by this alert.
  • Contact Smiths Medical 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 contacts for technical and clinical aspects. Change of address or removal from address list for Healthcare Commission.

> Pages 2-3

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

> Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 August 2008
Deadline (action complete): 2 September 2008

 

Page last modified: 22 July 2008