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MDA/2008/051 - Kimal safety fistula needle (all product codes and lots)

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/051
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 21 July 2008 at 10:30
Ref: MDA/2008/051

 

Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Kimal safety fistula needle (all product codes and lots).

>Page 2

Problem:
Kimal is aware of the potential for the unintentional retraction of the cannula into the protection sheath, which can result in exsanguination. As a result, Kimal is recalling all lots of the device.		  
Action by:
All staff associated with performing dialysis and plasmapheresis treatments.		  

Action:

  • Do not use these devices.
  • Identify and isolate any affected devices.
  • Contact manufacturer to arrange for return of device.
  

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
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 CSCI and Healthcare Commission.

>Pages 2-3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 24 July 2008
Deadline (action complete): 28 July 2008


Page last modified: 21 July 2008