Recall Z-0901-2014— Merit Medical Systems, Inc.

Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2013-12-18, terminated 2014-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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.

Classification

Class II

Status

Terminated

Initiated

2013-12-18

Terminated

2014-02-13

Firm location

South Jordan, UT, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.