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MDA/2008/025 - Frazier and Poole suction instruments used in surgery. Manufactured by ConMed Corporation

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/025
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: 14 April 2008 at 11:00
Ref: MDA/2008/025

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Frazier and Poole suction instruments used in surgery. Manufactured by ConMed Corporation.

>Page 2
Problem:
The sterility of some Frazier and Poole suction instruments may be compromised due to inadequate sealing of their packaging.		  
Action by:
Theatre and supplies department staff.		  

Action:

  • Identify potentially affected stock (see table on page 2).
  • Check that the packaging seal is intact by visual inspection.
  • Quarantine and do not use instruments with inadequately sealed packaging.
  • Contact ConMed Corporation to arrange return and replacement.
 

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 MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Pages 2-3
Appendix:
Manufacturer’s recall notice (in pdf only).

>Pages 4-6



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 28 April 2008
Deadline (action complete): 19 May 2008

Page last modified: 14 April 2008