FDA Device recall Z-0901-2014
Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure
- FDA Device
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of Radial Assist RAD BOARD, used to support the weight of a patient's arm and supplies for a medical procedure by Merit Medical Systems, citing 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 patie….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0901-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-12-18 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Merit Medical Systems |
| Distribution | GA, MN, NJ, TX, WV |
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
Identifiers
| code_info | lot B507171 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0901-2014%22
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