Welcome!

News Feed Item

SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet.

WILSONVILLE, Ore., Aug. 29, 2014 /PRNewswire-iReach/ -- SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet. 

Photo - http://photos.prnewswire.com/prnh/20140828/141361

SAM Medical Products announced today that it has begun notifying customers of a voluntary recall to address a potential issue with a clip used to secure the accessory strap used for the Axilla application of the SAM Junctional Tourniquet (SJT).  The company discovered through customer feedback and subsequent additional internal testing that a very low percentage of the clips in question failed during repetitive use in training. If this piece were to fail in actual use the operator may face a potential delay in using the SJT in the Axilla area. 

The company has not received any reports of patient injuries to date related to this issue nor has it been reported to fail during actual patient use.   "Despite the very low percentage of failures we have seen with this clip, we feel that it is in our customers' best interest to proactively replace all of the straps in the field" said Sam Scheinberg, Founder and CEO of SAM Medical Products.  "We understand how mission critical these devices are and stand behind the quality and reliability of all SAM products". 

SAM Medical had notified customers of the voluntary recall by letter and is arranging with its customers to rapidly replace the current axilla straps with an updated version.  All other indications of the SJT (Inguinal hemorrhage and pelvic fracture) are not impacted by this modification and perform as intended.  The U.S. Food and Drug Administration (FDA) and other regulatory bodies have been notified.  

For more information or questions related to this notification, please contact Customer Service at 1-800-818-4726 or (503) 639-5474 or email at [email protected].

The SAM Junctional Tourniquet has received 510K clearance for controlling inguinal hemorrhage, axilla hemorrhage, and pelvic fracture stabilization. Built upon the design of the SAM Pelvic Sling II (with over 250,000 patient treatments worldwide since its inception in 2003), the SJT stands alone in versatility, size and weight, as well as rapid application time to achieve hemorrhage control (less than 25 seconds in most cases).  The SJT is designed to control bleeding where standard tourniquets would not be effective.  

About SAM Medical Products

SAM Medical Products is committed to bringing innovative solutions to market that meet the challenging needs of emergency medicine, the military, and hospitals around the world.  Our product lines focus primarily on fracture management, hemorrhage control, and wound care, and include the SAM Junctional Tourniquet, SAM Splint, SAM Pelvic Sling II, SAM Soft Shell Splint, Blist-o-Ban, SAM Chest Seal, and Chito-SAM.  Headquartered in Wilsonville, OR, our products are distributed globally in over 60 countries.  Find out more at www.sammedical.com.

Media Contact: Will Fox, SAM Medical Products, 503-783-8915, [email protected]

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE SAM Medical Products

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain.
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
@DevOpsSummit has been named the ‘Top DevOps Influencer' by iTrend. iTred processes millions of conversations, tweets, interactions, news articles, press releases, blog posts - and extract meaning form them and analyzes mobile and desktop software platforms used to communicate, various metadata (such as geo location), and automation tools. In overall placement, @DevOpsSummit ranked as the number one ‘DevOps Influencer' followed by @CloudExpo at third, and @MicroservicesE at 24th.
SYS-CON Events announced today that T-Mobile will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. As America's Un-carrier, T-Mobile US, Inc., is redefining the way consumers and businesses buy wireless services through leading product and service innovation. The Company's advanced nationwide 4G LTE network delivers outstanding wireless experiences to 67.4 million customers who are unwilling to compromise on ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
Did you know that you can develop for mainframes in Java? Or that the testing and deployment can be automated across mobile to mainframe? In his session at @DevOpsSummit at 20th Cloud Expo, Vaughn Marshall, Sr. Principal Product Owner at CA Technologies, will discuss and demo how increasingly teams are developing with agile methodologies using modern development environments and automating testing and deployments, mobile to mainframe.
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
SYS-CON Events announced today that Hitachi, the leading provider the Internet of Things and Digital Transformation, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Hitachi Data Systems, a wholly owned subsidiary of Hitachi, Ltd., offers an integrated portfolio of services and solutions that enable digital transformation through enhanced data management, governance, mobility and analytics. We help globa...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across supply chain networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost and time for product recall as well as advance trade. Are you curious about Blockchain and how it can provide you with new opportunities for innovation and growth? In her session at 20th Cloud Exp...
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing be...
Back in February of 2017, Andrew Clay Schafer of Pivotal tweeted the following: “seriously tho, the whole software industry is stuck on deployment when we desperately need architecture and telemetry.” Intrigue in a 140 characters. For me, I hear Andrew saying, “we’re jumping to step 5 before we’ve successfully completed steps 1-4.”