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SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet.
Date:8/29/2014

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.  

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