Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medica...
FDA Recall #Z-0901-2014 — Class II — December 18, 2013
Product Description
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.
Reason for Recall
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
Recalling Firm
Merit Medical Systems, Inc. — South Jordan, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
11
Distribution
Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.
Code Information
lot B507171
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated