FDA-Device2018-06-20Class II
Part #: SAM XT-M, Model: Tactical Black or Military
The Seaberg Company Inc
Hazard
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.
Sold states
USA: CA, MD, OH, FL, ID, CO, CT, OR, AZ, IL, ME, MO, NY, SC, MI, AR, MT, CT, WA, TX, KY, NC, NJ, PA OUS: Australia, Canada, China, Columbia, Costa Rica, Europe (EU), Hong Kong, Iceland, India, Iraq, Israel, Japan, Kenya, Korea, Lebanon, Malaysia, Russia, Saudi Arabia, Singapore, South Africa, Thailand, UAE
Affected count
N/A
Manufactured in
27350 SW 95th Ave Ste 3038, N/A, Wilsonville, OR, United States
Products
Part #: SAM XT-M, Model: Tactical Black or Military
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2226-2018Don't want to check this manually?
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