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MDA/2007/048 - Devices for securing lines, tubes and drains: Drain-Fix 680M and 685M; Central-Gard 667M and 668M; Epi Fix 670M - All manufactured by Unomedical Ltd

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/048
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 5 June 2007 at 15:00
Ref: MDA/2007/048

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Devices for securing lines, tubes and drains:
Drain-Fix 680M and 685M; Central-Gard 667M and 668M; Epi Fix 670M.
All manufactured by Unomedical Ltd.

>Page 2

Problem:
A packaging problem that may affect one in six of the manufactured peel pouches may compromise the sterility of the devices.  Therefore the manufacturer is recalling all affected batches.

>Page 2

Action by:
Medical, nursing and procurement staff who have responsibility for purchasing and applying securement devices.		  

Action:

  • Ensure that all relevant staff are aware of this recall.
  • Identify and quarantine affected stock.  The model, lot numbers and NHS Supply Chain codes are listed overleaf.
  • Contact the manufacturer to organise the return and replacement of affected stock.
 

Distributed to:

NHS trusts in England - Chief Executives*
Commission for Social Care Inspection (CSCI) - Headquarters
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

>Pages 2-3

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

>Pages 3-4



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 26 June 2007
Deadline (action complete): 31 July 2007


Page last modified: 05 June 2007