FDA (Devices) recall action 80140
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Based 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 patient to stop arterial blood flow. There is a remote chance that a serious injury and/or death could occur as a result of the failure of the device.
The agency’s own wording, quoted from the enforcement report.
The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle could fail, posing a risk of serious injury or death.
The Seaberg Company is recalling SAM XT-M tourniquets because internal testing found stitches securing the buckle could fail, posing a risk of serious injury or death.
The Seaberg Company is recalling SAM XT-C tourniquets because internal testing showed stitches securing the buckle might fail, posing a risk of serious injury or death.