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HomeTACTICAL MEDICAL SOLUTIONS, LLC › SOF® TOURNIQUET RED CROSS VERSION

SOF® TOURNIQUET RED CROSS VERSION

TACTICAL MEDICAL SOLUTIONS, LLC · Model 5 · UDI-DI 00818630015482

GAX
10
510(k) clearances
89
Adverse events (2 deaths)
8
Recalls
334
Facilities

Description

THE NEW BENCHMARK FOR BLEEDING CONTROL The newest evolution of the SOF® Tourniquet sets the benchmark for prehospital tourniquets. Purposeful upgrades allow for smoother and faster one-handed and two-handed applications for the most effective bleeding control. Its innovative design comes from years of extensive research, material testing, and end-user feedback on and off the battlefield. It continues to evolve with your changing medical response needs when bleeding control is needed most. The SOF® Tourniquet easily slides over an arm or leg. It unclips at the buckle to fit around hard-to-reach areas, such as a trapped limb. In developing the SOF® Tourniquet, we asked customers about their experiences and the features that would be most important to them. The feedback gathered is shown in the tourniquet’s improved design and effectiveness. It is stronger, lighter, and easier to use so you can stop the bleed anywhere life takes you. Our patented SOF® Tourniquet was designed by a Special Forces medic while on deployment in Afghanistan in 2003 to save lives. It is still the preferred tourniquet for elite military forces and emergency responders worldwide.

Recalls

DateFirmReason
2020-12-28Mar-Med CoA failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in plac
2018-05-02The Seaberg Company IncBased on internal testing, results 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 pati
2018-05-02The Seaberg Company IncBased on internal testing, results 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 pati
2018-05-02The Seaberg Company IncBased on internal testing, results 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 pati
2015-08-31Pyng Medical CorporationOnce tested, it is required that the tourniquet be returned to its Ready position then placed in its packaging. Each tourniquet was tested for functionality, but in some cases, the
2014-08-05ICU Medical, Inc.ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially produ
2014-08-05ICU Medical, Inc.ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially produ
2014-08-05ICU Medical, Inc.ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially produ

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.