FDA-Device2014-11-05Class II
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
Sam Medical Products
Hazard
SAM Junctional Tourniquet (SJT) Auxiliary strap, model SJT 102 and SJT 112, is recalled because the snap hook on auxiliary strap broke during training demonstration.
Sold states
Worldwide Distribution: US (nationwide) in states of Ohio, Oregon, New Mexico, North Carolina, Texas and to the following countries: Australia, Canada, Hong Kong, Iceland, Japan, Lebanon, Singapore, Thailand, and United Kingdom.
Affected count
total 3633 units (3342 units in US and 291 units Outside US)
Manufactured in
27350 SW 95th Ave Ste 3038, N/A, Wilsonville, OR, United States
Products
SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112. The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0133-2015Don't want to check this manually?
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