{ "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": "191587", "product_res_number": "Z-0563-2022", "event_date_initiated": "2022-01-24", "event_date_created": "2022-02-04", "recall_status": "Open, Classified", "res_event_number": "89439", "product_code": "GDY", "k_numbers": [ "K780871" ], "product_description": "1. Arterial Line Kit 20ga x 6\"\n\n2. Arterial Line Kit /1 20ga x 6\"", "code_info": "1. Model: 400115A and Serial # 11377499, Expire Date: 10/27/2022  2. Model: 498100 and Serial # 11378381, Expire Date: 4/15/2026", "firm_fei_number": "1625425", "recalling_firm": "Argon Medical Devices, Inc", "address_1": "1445 Flat Creek Rd", "city": "Athens", "state": "TX", "postal_code": "75751-5002", "additional_info_contact": "Rebecca Ellis\n469-731-1410", "reason_for_recall": "Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.", "root_cause_description": "Mixed-up of materials/components", "action": "Urgent Product Recall Notice was send out to the affected customers on 01/24/2022 via registered mail:\n\nThe notification letter to each customer identify the specific lots and quantities that were shipped to that customer, and requesting to take the following action by customer.\n\n1. Complete and return product inventory sheet quickly as possible\n2. Notify/share the notification with anyone who needs to be aware within your organization or to any organization where the potentially affected products have been transferred.\n3. Return all affected product to Argon Athens facility using RGA# provided in the notification.\n\nIf you have any questions about the recall letter or about the recall action it describes in the notification, please contact Brian.Rogers@argonmedical.com. You may also contact Arbee.Cummings@argonmedical.com or Andrea.Wieczor@argonmedical.com", "product_quantity": "600 ea", "distribution_pattern": "US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.", "openfda": { "k_number": [ "K842572", "K802798", "K811769", "K934971", "K920356", "K950373", "K960236", "K913303", "K945866", "K771395", "K945332", "K955599", "K830202", "K940767", "K913302", "K953057", "K950370", "K953088", "K945336", "K812651", "K812017", "K800281", "K872807", "K935883", "K792630", "K953059", "K884790", "K955322", "K813286", "K790389", "K882707", "K882709", "K811632", "K894984", "K945553", "K941344", "K854714", "K832172", "K945606", "K972634", "K941522", "K831914", "K840541", "K942366", "K830260", "K953058", "K864529", "K914083", "K953062", "K781818", "K830511", "K920355", "K913794", "K940757", "K853742", "K790050", "K935910", "K872809", "K935993", "K953830", "K782107", "K822623", "K812831", "K944879", "K935882", "K940436", 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