US-based SAM Medical Products is voluntarily recalling its Accessory (Axilla) Strap for the SAM Junctional Tourniquet (SJT).
The company is implementing the recall, as the clips used in some of the straps failed during repetitive use. SAM discovered it through customer feedback and subsequent additional internal testing.
The operator will face a delay in using the SJT in the Axilla area, if the clip fails in actual use, noted SAM.
SAM Medical Products founder and CEO Sam Scheinberg said the company understand how mission critical these devices are and stand behind the quality and reliability of all products.
"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," Scheinberg added.
Developed based on the design of the SAM Pelvic Sling II, the SJT secured 510K approval to control inguinal hemorrhage, axilla hemorrhage, and pelvic fracture stabilization.
Headquartered in Wilsonville, Oregon, the company also produces SAM Splint, SAM Soft Shell Splint, Blist-o-Ban, SAM Chest Seal, and Chito-SAM.
The firm’s products are currently available in around 60 countries.