FREIWILLIGER PRODUKTRÜCKRUF:

FREIWILLIGER PRODUKTRÜCKRUF:

Urgent Field Safety Notice
SAM XT Extremity Tourniquets

Attention End-Users, Distributors and Customers:

For more than 30 years, SAM Medical has been guided by a strong commitment to producing the highest quality emergency medical devices, where living is the only return of investment that matters. Because of this SAM informed us about their decision to recall 

After internal testing of the SAM XT Extremity Tourniquets (SAM XTs) indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, SAM is conducting now a voluntary international recall of all unused SAM XTs, distributed from March 2017 through April 2018.

To date, there have been no reports of adverse health consequences received. The recall is being made with the knowledge of the Food and Drug Administration and other relevant Competent Authorities.
Production and replacement is currently underway.

We are working together with SAM on the recall and there are forms available to all Distributors, Sub-distributors and End-Users to return the necessary informations and prepare the return & replacement of the products.
You can find the English documents as of now here: 
https://bit.ly/2FEUXOf.  We are preparing translated versions in various languages at the moment on behalf of SAM for you to provide to your customers and end-users, which will be available asap. 

Learn more here: 
www.sammedical.com/xtrecall

If you have questions around the recall, the forms or the return of the product, please feel free to contact Terry O'Brien, our Water-Jel Quality Assurance and Regulatory Affairs Manager, by phone in our Hertford office or by email terry.obrien@waterjel.net. Terry will be be more than happy to guide you through the process. 

Marketing Support:
PDF Brochures, Instructions for Use, High Resolution Images are available in the WJ B2B Dropbox. Here is the link again: 
http://bit.ly/2EGhz1i

If you are missing something or if you are looking for some specific help, please do not hesitate to contact us any time. 

Your Water-Jel Team in Europe

07. MAI. 2018, 21:20 Uhr/