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MDA/2006/062 - Urine bag: Coloplast Conveen urine bag 1500ml, 90cm tube, non-sterile. Product code: 5062. Lot numbers: 546740, 568782, 576109.

Document details:

Type: Medical Device Alert
Series No: MDA/2006/062
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: 26 October 2006 at 14:00
Ref: MDA/2006/062
 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Urine bag: Coloplast Conveen urine bag 1500ml, 90cm tube, non-sterile.
Product code: 5062.
Lot numbers: 546740, 568782, 576109.
 

>Page 2

Problem:
Failure to drain urine due to blocked non-return valve. The manufacturer is recalling specific batches of the device.
 

>Page 2

Action by:
Continence advisors, nurses and all others involved in the use, supply and/or distribution of this device.
 

Action:

  • Identify and quarantine stock from these lot numbers.
  • Contact the manufacturer to arrange collection and replacement of affected stock.
 

Distributed to:

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

* via CE Bulletin

>Page 2

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

>Pages 2-3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 09 November 2006
Deadline (action complete): 27 December 2006


Page last modified: 26 October 2006