Urgent Recall of SAM XT Extremity Tourniquet Announced by SAM Medical

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. 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 Identification The 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. PART NUMBER MODEL LOT NUMBER...
Source: JEMS: Journal of Emergency Medical Services News - Category: Emergency Medicine Tags: News Industry News Source Type: news