SAM Medical Products Recalls Junctional Tourniquet
SAM Medical Products is voluntarily recalling its SAM Junctional Tourniquet due to a potential issue with a clip used to secure an accessory strap when the device is used in the armpit. If the clip fails, there could be a delay in using the SJT in this area, the company says.
The problem was discovered through customer feedback and verified with in-house testing. A recall notice was posted to the FDA’s website on Oct. 7.
The Wilsonville, Ore., devicemaker notified customers of the issue on Aug. 29, but has not received any reports of clip failure or patient injuries related to the issue.
“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.
The company will replace the straps with an updated version. Other indications of the SJT, such as inguinal hemorrhage and pelvic fracture, are not affected by the recall.
The SJT is cleared for use in controlling inguinal hemorrhage, axilla hemorrhage and pelvic fracture stabilization. It controls bleeding where normal tourniquets would not be effective, according to the company. — Kellen Owings
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