The Seaberg Company Inc recalls Part #: SAM XT-C, Model: Hi-Viz Blue

Recall date

May 2, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2228-2018

FDA classification

Class II

Brand / firm

The Seaberg Company Inc

Sold / distributed

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, Thail…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Part #: SAM XT-C, Model: Hi-Viz Blue