martes, 1 de octubre de 2024

SAM® XT TOURNIQUET RECALL: Torniquete SAM XT

Sustituyendo  mi SAM® XT por el  TIE (Torniquete Español) en mi IFAK Razón en el QR y/o enlace adjunto  by Dr. Ramon Reyes, MD @drramonreyesmd   

Aprobado el SAM XT por el DoD y autorizado a utilizar el logo Stop the Bleed      

Licensing Operations 4 December 2018
SUBJECT: STOP THE BLEED® - SAM Medical

TO WHOM IT MAY CONCERN

     The Department of Defense (DoD) is the owner of numerous U.S. and foreign trademark
registrations on the words STOP THE BLEED® and associated design. The Defense Media
Activity’s Trademark Licensing Office is the proponent agency for all licensing activities
associated with the STOP THE BLEED (STB) mark. In coordination with DoD’s Combat
Causality Care Research Program, it has the responsibility for ensuring that all licensed STB
products meet or exceed DoD’s specifications for quality and functionality.

     In accordance with the licensing requirements established by this office, the SAM XT series
tourniquets, an FDA Class 1 medical device, were submitted to our medical experts at the
Combat Causality Care Research Program for examination. After careful examination, they
determined that the SAM TX tourniquets were effective in reducing or stopping severe bleeding
when used in accordance with the manufacturer’s instructions and that they met all requirements
under the STB product licensing program.

     Having successfully passed DoD’s medical examination of their products and after fulfilling all
other requirement established by this office, SAM Medical was issued a license use the STOP
THE BLEED logo in association with the manufacture and sales of its SAM XT tourniquets.
That license remains valid as of the date of this letter.

     William S. Gardiner

Director

DMA Trademark Licensing Office

SAM® XT TOURNIQUET RECALL: Torniquete SAM XT  http://emssolutionsint.blogspot.com.es/2017/07/sam-xt-tourniquet.html

Les Esperamos en nuestro Grupo en TELEGRAM Soc. IberoAmericana de Emergencias

Sustituyendo  mi SAM® XT por el  TIE (Torniquete Español) en mi IFAK Razón en el QR y/o enlace adjunto  by Dr. Ramon Reyes, MD @drramonreyesmd     SAM® XT TOURNIQUET RECALL: Torniquete SAM XT  http://emssolutionsint.blogspot.com.es/2017/07/sam-xt-tourniquet.html  Les Esperamos en nuestro Grupo en TELEGRAM Soc. IberoAmericana de Emergencias https://t.me/joinchat/FpTSAEHYjNLkNbq9204IzA   Todos Nuestros VIDEOS en YouTube 

Todos Nuestros VIDEOS en YouTube https://www.youtube.com/c/RamonReyes2015 

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 to us. After internal testing of our SAM XT Extremity Tourniquets (SAM XTs) indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, we are conducting 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. This recall is being made with the knowledge of the Food and Drug Administration and other relevant Competent Authorities. Production and replacement is currently underway. Learn more here: http://emssolutionsint.blogspot.com.es/2017/07/sam-xt-tourniquet.html

SAM Medical has determined that, in rare cases, the stitches of the SAM XT Extremity Tourniquet (SAM XT) securing the buckle to the nylon belt may fail, posing a potential risk when used on a human patient to stop arterial blood flow. To date, there have been no reports of adverse health consequences received. This product has been sold worldwide since March 2017 by SAM Medical, and other distributors.

Customer safety is always SAM Medical's top priority, and we have voluntarily decided to recall this product. If you have an unused or unopened  SAM XT, please follow the process below to send back through your distribution channel. In exchange, we will provide you with a new SAM XT. 

This program only applies to the SAM XT Extremity Tourniquet which is shown to the right. The SAM XT comes in three colors: Tactical Black, Hi-Viz Orange and Hi-Viz Blue, which are also shown on this web page. 

IDENTIFY BY THE IFU 

Compare your tourniquet to the images in Figure A.1. An affected tourniquet will not have the “Box X Stitch” icon on the upper right of the folded Instructions For Use (IFU) insert. Tourniquets not affected will display the “Box X Stitch” icon on the upper right of the folded IFU.

IDENTIFY BY STITCH PATTERN

Compare your tourniquet to the images in Figure A.2. An affected tourniquet will have a multi-pass straight lockstitch. Tourniquets not affected will have a “Box X” stitch (stitching is highlighted in red for display purposes only).

IDENTIFY BY LOT NUMBER 

If your tourniquet has been removed from the packaging please compare to the images in Figure A.3. You may find the lot number etched on the front of the Buckle or on the printed shipping label on the original shipping case. An affected tourniquet has a lot number of XT1711 - XT1811. Tourniquets not affected will have lot numbers from XT1812 and onward.

EXCHANGE PROCESS

SAM Medical is notifying all distributors and direct sales customers to arrange for a return of all recalled product. Distributors and customers have been asked to return all affected product back through their distribution channel. To participate in this recall, please take the following actions:

Immediately examine your inventory and quarantine product subject to recall.

Immediately discontinue use and distribution of the identified lot number.

Return product through your distribution channel.

NOTE: A Returned Material Authorization (RMA) must be obtained to send back unused (case boxes, individual wrapped or unwrapped and never used) products.

A pre-paid return label will be provided to you for the product return; return shipment is free of charge. For the RMA, contact your distributor’s Customer Service.

Please provide the total quantities of SAM XTs by color, as well as the shipping container's weight and dimensions used for the exchange in order to generate the RMA return shipping documentation. Contact SAM Medical via email at xtrecall@sammedical.com.

If you have further distributed this product, please identify those customers and notify them at once of this product recall.

This recall is being carried out to the user level. 

http://www.sammedical.com/xtrecall

SAM-XT VOLUNTARY RECALL PROGRAM

TOURNIQUETS HAVE EVOLVED | SAM® XT rises above other tourniquets as the preferred choice due to its rapid application using TRUFORCE™ technology, an auto-lock buckle that eliminates tourniquet slack by activating innovative baseline force control. http://samxt.com

Enlace distribuidor en España

by Dr. Ramon Reyes, MD

C.A.T "CAT" vs SAM® XT TOURNIQUET

SAM® XT TOURNIQUET

Torniquete de extremidades. Diseño inteligente para una aplicación rápida y precisa. El innovador diseño de SAM XT requiere menos vueltas del molinete al ajustarse con precisión al contorno de la extremidad gracias a la hebilla truforce. Excede las pautas de durabilidad estipuladas por la norma MIL-STD 810G

1 BANDA PARA CONTROLAR LA HORA DE APLICACIÓN

El velcro mantiene su funcionalidad cuando está totalmente sumergido, proporcionando la máxima seguridad con la climatología más adversa. El material exterior está optimizado para la visión nocturna.

2 GANCHO EN C DEL MOLINETE

Fija la posición de la varilla metálica del molinete gracias a su intuitivo diseño en ángulo, por lo que el molinete se puede fijar en su sitio de forma más fácil y eficiente.

3 PLACA TRUFLEXTM

Fabricada en nailon, es altamente resistente y duradera. Diseñada para dirigir la fuerza ejercida con la máxima flexibilidad, adaptándose en extremidades más pequeñas sin romperse.

4 HEBILLA TRUFORCETM

La innovadora tecnología de auto-bloqueo se activa al aplicar una fuerza de 98 newtons, eliminando la holgura que se encuentra habitualmente en otras aplicaciones de torniquete.

5 VARILLA METÁLICA DEL MOLINETE

Mecanizada a partir de barras extruidas de auténtico aluminio 6061-T6 resistente y ligero para una fiabilidad constante en comparación con los compuestos de plástico.

6 CINTAS DE PRECISIÓN

El sistema de orificios a intervalos hecho de malla de una sola capa, 100 % nailon, se auto-bloquea con la hebilla TRUFORCETM para aumentar la resistencia cuando se aplica en las condiciones más duras.

7 LENGÜETA DE PRECISIÓN

Su diseño intuitivo permite una aplicación más rápida y más fácil del torniquete. El material está optimizado para la visión nocturna.

Distribuidor exclusivo en España http://www.adarotecnologia.com/producto/sam-xt-torniquete-de-extremidades/

VIDEO SAM XT DR. RAMON REYES DIAZ

SAM XT POR UN NIÑO BY DR. RAMON REYES DIAZ

DR. RAMON REYES DIAZ VIDEO SOBRE TORNIQUETES

DR. RAMON REYES DIAZ TORNIQUETES SAM XT

SAM XT TORNIQUETE DE EXTREMIDAD

SAM® XT TOURNIQUET

Hemos estado entrenando al personal de escolta del Ministro de Defensa de Republica Dominicana y en las practicas del uso del torniquetes hemos utilizado el CAT, SAM XT, SICH, TIE, DINPRO, los Mejores valorados por instructores y más de 48 Estudiantes;

1. DINPRO ganador Ucrania https://emssolutionsint.blogspot.com/2022/12/torniquete-dinpro-hecho-en-ucrania.html

2. SICH Ucrania https://emssolutionsint.blogspot.com/2023/05/torniquete-strengthened-individual.html

3. TIE España https://emssolutionsint.blogspot.com/2017/01/torniquete-compresor-de-emergencias.html

Mayo 23-25 del 2023

Ministerio de Defensa de la Republica Dominicana

Advertencia: El Dr. Ramon Reyes, MD no tiene compromisos personales, ni comerciales con ninguna de las marcas anteriormente mencionada

Contactos con el Dr. Ramon Reyes, MD https://emssolutionsint.blogspot.com/2016/12/dr-ramon-reyes-diaz-md-emt-t-dmo.html