FDA-Device2014-02-05Class II
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead
Merit Medical Systems, Inc.
Hazard
Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There
Sold states
Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
Affected count
11
Manufactured in
1600 West Merit Parkway, South Jordan, UT, United States
Products
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure. The Merit RAD BOARD is a rigid and stiff body board intended for use for various medical purposes. RAD BOARD was specifically designed to support the weight of a patient's arm and supplies for medical procedure, in order to have optimal access to upper extremity vasculature, including radial and brachial arterial and venous access. The RAD BOARD is partially lined with a layer of lead-free Xenolite TB for additional radiation scatter protection.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0901-2014Don't want to check this manually?
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