—#124977

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.

FDA product code: BWN — Table And Attachments, Operating-Room
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: lot B507171

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Merit Medical Systems, Inc.sent a letter voluntarily recalling one lot (B507171) of RAD BOARD" RB100 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 have been no reports of patient harm or injury from Merit customers as a result of this issue. Merit has chosen to remove this lot from the field by replacing the unlabeled RAD BOARDs. Merit requests that customers stop using these devices immediately until the product has been replaced by their Merit sales representative. Customers with questions were instructed to call 1-801-208-4344 or 1-801-208-4365. For questions regarding this recall call 801-208-4301.

Recalling firm

Firm: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway, South Jordan, Utah 84095

Distribution

Distribution pattern: Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.

Timeline

Recall initiated: 2013-12-18
Posted by FDA: 2014-01-30
Terminated: 2014-02-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124977. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.