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The Seaberg Company Inc recalls Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Recalled June 20, 2018 · FDA recall Z-2227-2018 · The Seaberg
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. · FDA Class II
Units
N/A
Sold at
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
Description
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.
Product
Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian
Manufacturer(s)
The Seaberg Company Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →