{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "124977", "product_res_number": "Z-0901-2014", "event_date_initiated": "2013-12-18", "event_date_posted": "2014-01-30", "recall_status": "Terminated", "event_date_terminated": "2014-02-13", "res_event_number": "67206", "product_code": "BWN", "product_description": "Radial Assist RAD BOARD, used to support the\r\nweight of a patient's arm and supplies for a medical procedure.\r\n\r\nThe 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.", "code_info": "lot B507171", "firm_fei_number": "1721504", "recalling_firm": "Merit Medical Systems, Inc.", "address_1": "1600 West Merit Parkway", "city": "South Jordan", "state": "UT", "postal_code": "84095", "additional_info_contact": "Paul Kennedy\n801-208-4301", "reason_for_recall": "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_description": "Labeling Change Control", "action": "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\r\nto 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.\r\nCustomers with questions were instructed to call 1-801-208-4344 or 1-801-208-4365.\r\nFor questions regarding this recall call 801-208-4301.", "product_quantity": "11", "distribution_pattern": "Worldwide Distribution - USA including NJ, TX, WV, MN, GA, and Internationally to Mexico and Japan.", "openfda": { "k_number": [ "K812395", "K935441", "K902865", "K860177", "K823772", "K820574", "K791859", "K852332", "K910783", "K925005", "K843121", "K832340", "K942699", "K792569", "K875291", "K884558", "K802271", "K922288", "K873272", "K812396" ], "registration_number": [ "", "3021723305", "3030192580", "3005748481", "3013404959", "2031963", "3014383485", "9680168", "3003418325", "3013408788", "3015806723", "9610612", "3006098219", "3007913191", "3016678414", "3007417753", "3013700547", "3031564213", "3006950086", "3003890514", "3003102481", "1825034", 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"878.4950", "device_class": "1" } } ] }