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MDA/2007/066 - Vaginal specula: all single-use Cusco screw type vaginal specula manufactured by North Eos

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/066
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price:
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Note: Since the issue of this Alert, the manufacturer can now confirm that all Cusco screw type specula supplied after May 2007 have been sterilised using gamma irradiation. All labelling has been changed to indicate this. (Jan 08)

 

Issued: 23 July 2007 at 11:00
Ref: MDA/2007/066
 
Immediate action
 Tick mark
Action
 
Update
 
Information request


Device:
Vaginal specula: all single-use Cusco screw type vaginal specula manufactured by North Eos.

>Page 2 

Problem:
All single-use Cusco screw type specula supplied before 27 February 2007 have been wrongly labelled as sterile instead of clinically clean. Other models of vaginal specula from this manufacturer are not affected.

>Page 2

Action by:
Users of these devices.

 

Action:
Any product labelled as sterile should be withdrawn from use to avoid confusion over its sterility status.

 

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*
Health Protection Agency (HPA) - Directors

* 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.

>Page 3



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 20 September 2007
Deadline (action complete): 04 October 2007


Page last modified: 07 February 2008