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MDA/2007/091 - Wound drainage set for use in theatres: Privac pre-evacuated drainage set with 10ch drain and 600ml drainage bottle. Product code 24760. Batches 12032007 and 07052007

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/091
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

Page 1

Issued: 04 December 2007 at 12:00
Ref: MDA/2007/091

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Wound drainage set for use in theatres: Privac pre-evacuated drainage set with 10ch drain and 600ml drainage bottle.  Product code 24760.  Batches 12032007 and 07052007.

>Page 2

Problem:
Debris from the manufacturing and packaging processes has been found in the sterile packaging of some wound drainage sets from these batches. If used, there is a risk of introducing debris into the patient’s wound.

 
Action by:
All staff involved with the placement of wound drains and the purchase, supply and distribution of these devices.		  

Action:

  • Identify, quarantine and do not use any stock from the affected batches.
  • Contact ProCare, the UK distributor, to arrange the return and replacement of products from the affected batches.
 

Distributed to:

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


* via CE Bulletin

>Page 2

Contacts:
Details of supplier 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): 17 December 2007
Deadline (action complete): 02 January 2008

Page last modified: 04 December 2007