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Safety

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
 

 

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

Contact:
Consumer:
1-800-818-4726 or (503) 639-5474 or email at customerservice@sammedical.com

FOR IMMEDIATE RELEASE — August 29, 2014 – 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 customerservice@sammedical.com.

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.

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