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MDA/2007/049 - Single-use capillary blood sampling device: Microtainer® Safety Flow Lancets manufactured by BD Preanalytical Systems.

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/049
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 11 June 2007 at 11:00
Ref: MDA/2007/049

 

 

 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Single-use capillary blood sampling device: Microtainer® Safety Flow Lancets manufactured by BD Preanalytical Systems.
Product codes 366354, 366355 and 366358.

>Page 2

Problem:
Potential for a sharps injury to patient or user as the blade may become loose and then separate from the main body on activation of the device. The manufacturer has recalled the affected lot numbers of these products.

>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.
  • Identify, remove from the supply chain, and quarantine all stock from affected lots (see overleaf).
  • Contact BD Preanalytical Systems to arrange for the return and replacement of products from affected lots.
  

Distributed to:

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

* via CE Bulletin

>Pages 2-3

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.

>Page 3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 25 June 2007
Deadline (action complete): 11 July 2007


Page last modified: 11 June 2007