Urgent Recall of SAM XT Extremity Tourniquet Announced by SAM Medical

first_imgIf you purchased product directly from SAM Medical:1. Immediately examine your inventory and quarantine product subject to recall pursuant to the identification instructions above.2. Immediately discontinue use and/or distribution of any affected products.3. If you received a recall information packet from SAM Medical, follow the instructions in that packet for return of the recalled product.4. If you have not received an information packet from SAM Medical by May 16, 2018, please contact the company at [email protected] WILSONVILLE, OR — SAM Medical today announced it is conducting a voluntary international recall of all unused SAM XT Extremity Tourniquets (SAM XT). The company initiated the recall after internal testing indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, 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 recall is being made with the knowledge of the Food and Drug Administration and other relevant Competent Authorities.Product IdentificationThe recall involves all unused SAM XTs manufactured with the multi-pass straight lockstitch (Fig A.2), distributed from March 2017 through April 2018, with the following lot numbers. The lot number is located on the face of the buckle. If you purchased product from a party other than SAM Medical:1. Immediately examine your inventory and quarantine product subject to recall pursuant to the identification instructions above.2. Immediately discontinue use and/or distribution of any affected products.3. Contact the seller of the product and ask for instructions for return of all unused SAM Medical XTs through that distributor.4. If you do not have information on where you purchased the SAM XT, please contact the company at [email protected] with questions may contact the company at +1 800-580-3519 between the hours of 8:00 a.m. and 5:00 p.m. PT. Customers may also contact the company by email at [email protected] or through the website at www.sammedical.com/xtrecall.About SAM MedicalFor over 30 years, SAM Medical has developed and manufactured innovative medical products used for military, law enforcement, emergency, wilderness and sports medicine, and pre-hospital care around the world. A resounding favorite of medical professionals, SAM Medical’s lineup of products is engineered to preserve life. Innovations include SAM XT Extremity Tourniquet, SAM Splint, SAM Chest Seal, SAM Junctional Tourniquet, SAM Pelvic Sling, ChitoSAM, and SAM Soft Shell Splint. For more information, visit sammedical.com. Note from JEMS Editor-in-Chief A.J. Heightman on the SAM XT tourniquet recall:As an educator and advisor on MCI management, I want to commend SAM Medical for their voluntary recall of their SAM XT Extremity Tourniquets (SAM XT) after internal testing indicated that a failure of the stitches securing the buckle to the nylon belt could occur, and that this poses a potential risk when used on actual patients. Although the FDA is aware of the voluntary recall, they aren’t requiring it to occur.It’s a noble gesture by a company with a solid reputation in an effort to ensure that actual field failures don’t occur. Hi-Viz Orange or Civilian Hi-Viz Blue To help identify whether you have a tourniquet that is subject to the recall, in addition to the lot numbers in the prior table, please read Figures A.1 and Figure A.2. RemedyAll SAM XTs are now being manufactured with a “Box X” stitch which produces an inherently stronger stitch pattern. In addition, the company initiated more extensive simulated-use testing to ensure the revised stitching process is consistently reliable. Production and replacement of all recalled SAM XTs with the improved stitching is currently underway.Notifications MadeConcurrent with this press release, SAM Medical is notifying all SAM XT distributors and direct sales customers by email and signature-required postage. Each customer will receive instructions on how to arrange for a return of all recalled product. Customers and distributors must return all unused affected product through their distribution channel. SAM XT-C SAM XT-B XT1808 thru XT1811 Tactical Black or Military SAM XT-M XT1711 thru XT1811 XT1711 thru XT1811 Contact:Customer Service+1 [email protected] PART NUMBER Figure A.2An 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) MODEL LOT NUMBERSw/ multi-pass straight lockstitch(see Fig A.2) Figure A.1An 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.last_img read more

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Rock of Ages owner buys famous French limestone quarries

first_imgRock of Ages Corporation,Vermont Business Magazine The parent company of Barre’s Rock of Ages, Polycor Inc of Quebec, announced today the acquisition of four famous limestone quarries located in Burgundy, France, previously belonging to Rocamat. The French quarries have been used for centuries to build landmarks across Europe. Vermont-based Swenson Granite and Rock of Ages are part of the Polycor family of brands. As a result of this acquisition, local Rock of Ages customers will now have access to this heritage French limestone along with the American granites.France is currently sourcing stone from Vermont’s quarries for its restoration projects. Notably, La Grande Arche de la Défense (in Puteaux, west of Paris) designed by Johann Otto von Spreckelsen, has been restored with Vermont’s Bethel White Granite. The Bethel white is taking the place of Italian marble. Bethel white also was chosen for the 74-story home of the Abu Dhabi National Oil Company in the United Arab Emirates.The Grand Arch was built to celebrate the bicentennial of the French Revolution (July 14, 1789, storming of the Bastille). The concrete, granite, marble and glass arch is also an office building with 35 floors of office space. The massive structure is large enough to fit the Notre-Dame Cathedral inside its 348-foot span and 361-foot high rooftop terrace. Courtesy Jennifer Smiga (Marketing).Polycor is known for its vast portfolio of stones, many of which are the building blocks of the US’ cherished heritage sites such as the Washington Monument benches, New York City’s Saint Patrick’s Cathedral and Union Station.The acquisition of these French limestone quarries allows Polycor to further diversify its offering, now including the well-known Massangis stone. For centuries, this limestone has been used to build some of the most important structures in France, including the Louvre Museum, the Louis Vuitton Foundation and the base of the Eiffel Tower.Here in the US, this iconic limestone clads the exterior of the modernist Katzen Arts Center at American University (link is external)in Washington, DC.This acquisition furthers Polycor’s global presence as the company aims to expand its scope of activities and line of products from one continent to another. Thanks to Polycor’s existing sales infrastructure, US and world clients alike will now be able to purchase this iconic French limestone in a variety of shapes and sizes for residential and commercial projects: slabs, tiles, blocks and custom made projects.Polycor plans to invest equipment and infrastructure updates, as well as return 18 employees back to their original activities at the French quarries, now under Polycor’s leadership. SEE RELATED STORY HERE(link is external)About Polycor Inc.Founded in 1987 in Quebec City, Canada, Polycor Inc. is a leader in the natural stone industry in North America. The company’s growth through acquisitions, including U.S. based Rock of Ages and Swenson Granite in September 2016, demonstrates its position as a leader. Polycor Inc. employs nearly 900 people and owns over 30 quarries and 15 manufacturing plants across Canada, the United States and now, France. For more information, please visit our website: polycor.com/incSource: Quebec, July 9, 2018 – Polycor Inclast_img read more

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Football Conducts Fan Day Scrimmage; Nobles Named Week One Starter

first_imgQuarterback Kaleb Nobles completed 6-of-8 passes for 77 yards and threw three touchdowns. At the end of the scrimmage, UWF head coach Pete Shinnick commented on how consistent the graduate transfer from Valdosta State had been through camp. “I’m pleased with Kaleb tonight and he stepped up and found a good rhythm so that was nice to see,” Shinnick said. “If we started today, Kaleb would be the guy and the last couple days that has played itself out. He started 12 games over his career and he’s got that experience and brings a nice calm to the offense.”Redshirt freshman Grey Jackson split time with the first and second team offense Thursday, completing six passes for 39 yards and a touchdown.”Grey is going to play (at Ave Maria),” Shinnick added. “He’s going to play in the first game and we expect hime to continue to grow and continue to develop.”For the blue team, sophomore Kalu Onumah had a very strong performance, leading his unit to a long drive that he capped with a 1-yard rush for a score. He was 7-for-11 for 113 yards through the air and 27 yards on the ground.The squad will take a recovery day on Friday to regain their legs before opening preparation for Ave Maria on Monday afternoon. PENSACOLA, Fla. – The UWF football team conducted a 74-play scrimmage as part of its inaugural Fan Day in front of more than 1,400 fans at the University Park Turf Field Thursday night.The students, boosters, friends and players’ family members in attendance were treated to a number of strong offensive performances as the team was split into a blue team and white team, as opposed to the offense and defense from last week’s exercise.center_img  Print Friendly Versionlast_img read more

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