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MDA/2007/057 - Eliminator esophageal PET balloon dilator and pyloric/colonic PET balloon dilator manufactured by ConMed Corporation

Document details:

Type: Medical Device Alert
Series No: MDA/2007/057
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 02 July 2007 at 14:00
Ref: MDA/2007/057


Tick mark
Immediate action
 
Action
 
Update
 
Information request

 

Device:
Eliminator esophageal PET balloon dilator and pyloric/colonic PET balloon dilator manufactured by ConMed Corporation.

>Page 2

Problem:
Various labelling errors and inconsistencies have been identified, which can result in the use of an incorrect balloon size.

>Page 2

Action by:
Gastroenterologists, endoscopy staff, theatre staff and those responsible for the purchase and storage of these devices.
 

Action:

  • Identify the affected lot numbers on the outer box of the product before use (see overleaf for affected lot numbers and how to interpret format).
  • Quarantine affected devices.
  • Contact ConMed to arrange return and replacement of affected stock.
 

Distributed to:

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

* via CE Bulletin

 

>Page 3

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

>Page 3

 

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 10 July 2007
Deadline (action complete): 07 August 2007


Page last modified: 07 February 2008