Vag Illuminator Action

2016-03-23  Stop ship lifted: orders now processing with with labels included.

KleenSpec Corded Illumination System Field Safety Action

Affected Materials: 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816

US/CUpdated March 23, 2016:  SAP Order Process for Additional Label Requests

End User Inquiries:  

Q: I have a letter about this- Is this a recall?

A: This is not a recall. Customer may continue to use the unit as intended, as long as they use the power cord and transformer that comes with the unit. 

Q: We received your letter about the vaginal illuminator- who shall I send it to in our organization?

A: Instruct end user customer to provide the letter to Biomed or  head of nursing

Q: We received a letter but that business is no longer at this address - what should I do with it?    

A:  Instruct end user customer to return to sender if possible.  If they refuse, please document address information from the label on this google sheet.

   Info for Distributors: Welch Allyn is sending letters (with labels enclosed) to your end user customers who have purchased KleenSpec Corded Illumination System.  Customers will receive letters beginning January 2016, and continuing over the next few months. (See FAQs)  Distributor does not have to take any action.

You may send Distributor or End Customers copy of the below customer letter and External FAQs, if requested.

EPIC                Overview        

Internal FAQs  

External FAQs (may be sent to customer on request)

US End User Customer Letter         US/C Distributor Letter, English

Canada End User Customer Letter      Canada Distributor Letter, English

Canada Distributor Letter, French Canadian

EMEA End User Customer Letters by Country/Language:

Danish      English    German    Greece    Italy    Netherlands

Norway    Poland    Portugal    Russia    Spanish