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MDA/2007/086 - Surgical tool bit/burr - Anspach cutting burrs with expiry dates from June 2008 to August 2011 (inclusive)

Document details:

Type: Medical Device Alert
Series No: MDA/2007/086
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 13 November 2007 at 14:00
Ref: MDA/2007/086


 
Immediate action
Tick mark
Action
 
Update
 
Information request


Device:
Surgical tool bit/burr – Anspach cutting burrs with expiry dates from June 2008 to August 2011 (inclusive).

>Page 2

Problem:
Possible breakdown of packaging leading to compromise of the sterile barrier.

>Page 2

Action by:
Theatre staff and supplies departments.
 

Action:

  • Check stock.
  • Quarantine affected devices (see appendix for list of relevant catalogue numbers).
  • Return to the supplier’s representative.
 

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

Appendix:
List of catalogue numbers of affected devices (in pdf only).

>Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 21 November 2007
Deadline (action complete): 19 December 2007


Page last modified: 07 February 2008