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MDA/2007/006 - Chest drain: Portex chest drainage system with adjustable straw

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/006
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: 22 January 2007 at 11:00
Ref: MDA/2007/006


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Chest drain: Portex chest drainage system with adjustable straw. Product code 200/870/000, lot number 489962.
Manufactured by Smiths Medical.

>Page 2

Problem:
Failure to create a seal when the system is connected to the chest drainage bottle leaving the patient at risk of a pneumothorax. The manufacturer is recalling one lot of this device.

>Page 2

Action by:
All theatre staff, ward staff and those involved in the supply and/or distribution of this device.		  

Action:

  • Ensure that all relevant staff are aware of this recall.
  • Identify and remove all affected stock (lot number 489962) from use.
  • Contact the manufacturer to arrange collection and replacement of stock from this lot number.
  

Distributed to:

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

* 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



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 February 2007
Deadline (action complete): 05 March 2007


Page last modified: 07 February 2008