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MDA/2007/062 - Laryngoscope blades: Falcon single-use paediatric Miller blades size 00, 0 &1, supplied by Draeger Medical UK

Document details:

Type: Medical Device Alert
Series No: MDA/2007/062
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 7
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 14 August 2007 at 14:30
Ref: MDA/2007/062


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Laryngoscope blades: Falcon single-use paediatric Miller blades size 00, 0 & 1, supplied by Draeger Medical UK.

>Page 2

Problem:
Poor illumination of the airway and heating of the blade due to manufacturing problems with the bulb. The manufacturer is recalling all potentially affected devices, see UK distributor and manufacturer recall letters in the Appendix (in pdf only).
 
Action by:
Anaesthetists, operating department practitioners, and anaesthetic nurses in operating theatres. Medical and nursing staff in paediatric intensive therapy units, A&E departments, maternity units and paediatric wards.
 

Action:

  • Ensure that all relevant staff are aware of this recall.
  • Identify and quarantine all stock.
  • Contact the supplier to organise the return and replacement of all stock.
  • Where there are no alternatives available, the users may continue to use these providing the device is fully tested before use, in accordance with the manufacturer’s recommendations for the “Beam Focus Test” (see the Appendix).
 

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:

  • UK distributor’s cover letter and fax back form
  • Manufacturer’s recall advisory letter to customers
  • Manufacturer’s “Beam Focus Test”

>Pages 4-7



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 29 August 2007
Deadline (action complete): 12 September 2007


Page last modified: 07 February 2008