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
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.
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 email@example.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.
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
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
Bleeding Control Basic by American College of Surgeons and The Hartford Consensus IV StopTheBleed "Stop the Bleed"
5th McSwain EMS Trauma Conference "Symposium" 10 Nov 2017 / PHTLS FOUNDER Norman E. McSwain, Jr., MD, FACS. 1937-2015