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MDA/2008/004 - Umbilical cord clamp clipper manufactured by Unomedical Ltd. Product reference: 84006182

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Document details:

Type: Medical Device Alert
Series No: MDA/2008/004
Audience: Healthcare Professionals
Published:
Format: Electronic and Paper
Size: A4
Pages: 5
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

Related information:

MHRA pages:

Page 1

Issued: 30 January 2008 at 15:00
Ref: MDA/2008/004

  

 
Immediate action
Tick mark
Action
 Tick mark
Update
 
Information request

 

Device:
Umbilical cord clamp clipper manufactured by Unomedical Ltd. Product reference: 84006182
NHS Supply Chain catalogue code: FFK004
Affected lot number: 163136

>Page 2

Problem:
There is the potential for the blade to fall out of this device or break during use.  This is an expansion of a recall previously carried out in November 2006, and referred to in MDA/2007/033.

>Page 2

Action by:
Maternity units, neonatal intensive care units, midwives in the community, obstetricians.
  

Action:

  • Check stock and quarantine devices with affected lot number.
  • Return affected products to the manufacturer for replacement (contact details on page 2).
 

Distributed to:

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

* 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

Appendix:
Manufacturer’s recall notice (in pdf only).

>Pages 4-5



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 February 2008
Deadline (action complete):  03 March 2008


 

Page last modified: 30 January 2008