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MDA/2005/059 - Astra Tech Ltd Exudrain, Exudrain Mini and AbdoVac vacuum wound drains

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Document details:

Type: Medical Device Alert
Series No: MDA/2005/059
Audience: Healthcare professionals
Published:
Format:
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Ref. MDA/2005/059
Issued: 03 November 2005

IMMEDIATE ACTION  
ACTION Tick mark
UPDATE  
INFORMATION REQUEST Tick mark


  Further Information
DEVICE:
Astra Tech Ltd Exudrain, Exudrain Mini and AbdoVac vacuum wound drains.

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PROBLEM:
Potential for leakage between the bulb and the exit connector which may lead to one or more of the following problems:

  • Conversion of the system from active to passive drainage (loss of vacuum).
  • Increased risk of infection on breaking the closed circuit, should the device need to be changed.
  • Exposure of healthcare workers to exudate.

A manufacturer initiated recall of products from this range is ongoing.

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ACTION BY:
Supplies departments and all staff responsible for wound drain placement and care.		  

ACTION:

  • Ensure that all relevant staff are aware of this recall.
  • Identify and quarantine devices which are affected by this recall.
  • Return unused devices affected by the recall to Astra Tech Ltd.
  • Ensure that any problems encountered with devices from this range are reported to Astra Tech Ltd and MHRA.

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DISTRIBUTED to:

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

* via CE Bulletin

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

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> Further information supplied in the following pages.

Page last modified: 07 February 2008