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MDA/2007/022 - Single-use capillary blood sampling device: Unistik 3 Normal, Unistik 3 Comfort and Unistik 3 Neonatal & Laboratory devices. Manufactured by Owen Mumford. Product codes AT1002, AT1042 and AT1052

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/022
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: 14 March 2007 at 15:30
Ref: MDA/2007/022


 

 
Immediate action
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Action
 
Update
 
Information request


Device:
Single-use capillary blood sampling device: Unistik 3 Normal, Unistik 3 Comfort and Unistik 3 Neonatal & Laboratory devices.  Manufactured by Owen Mumford.  Product codes AT1002, AT1042 and AT1052.		  

>Page 2
Problem:
Potential for needlestick injury to users and damage to a patient’s sampling site due to a manufacturing fault.  The manufacturer recalled five batches of these products that were distributed during the period 06 September to 07 November 2006.

>Page 2
Action by:
All healthcare and care workers involved in the purchase, supply, distribution or use of these devices.		  

Action:

  • Ensure that all relevant staff are aware of this recall.
  • Stop using product from the affected batches.
  • Identify, remove from the supply chain and quarantine all stock from the affected batches.
  • Contact Owen Mumford to arrange the return and replacement of devices from the affected batches.
 

Distributed to:

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

* 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): 21 March 2007
Deadline (action complete): 16 April 2007

 

Page last modified: 14 March 2007