{ "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": "175982", "product_res_number": "Z-0294-2020", "event_date_initiated": "2018-10-16", "event_date_created": "2019-11-05", "recall_status": "Terminated", "event_date_terminated": "2021-06-15", "res_event_number": "83633", "product_code": "DRS", "product_description": "Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.", "code_info": "Lot number 11232311", "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": "Ms. Rebecca Ellis\n903-675-9321", "reason_for_recall": "The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.", "root_cause_description": "Equipment maintenance", "action": "The recalling firm began issuing letters dated 10/16/2018 on 10/16/2018 via registered mail identifying the issue and the action to be taken by the customer.", "product_quantity": "Total number in recall for all products in dist: 49,130 units", "distribution_pattern": "Distribution was nationwide. 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