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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Merit Medical Systems, Inc.
- 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
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