The Recall Desk
ModerateFDA (Devices)·Z-0901-2014·Announced 2014-02-05

Merit Medical Systems Recalls RAD BOARD Devices Due to Missing Labels

Merit Medical Systems is voluntarily recalling one lot of RAD BOARD devices because missing labels may allow incorrect orientation, potentially obscuring patient anatomy during fluoroscopy.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a voluntary precautionary recall for a labeling defect that could theoretically obscure anatomy during a procedure, but no injuries or illnesses are reported.

Plain-English summary

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. If this occurs, the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. The RAD BOARD is a rigid and stiff body board intended to support the weight of a patient's arm and supplies for medical procedures, specifically designed to provide optimal access to upper extremity vasculature.

The recall affects 11 units distributed worldwide, including the United States (NJ, TX, WV, MN, GA) and internationally to Mexico and Japan. No specific instructions for consumers are provided in the source text.

The recalled product

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 patie
Affected units
11

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • lot B507171

Distribution

Distributed in 5 states: