{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "175974", "product_res_number": "Z-0288-2020", "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", "k_numbers": [ "K810637" ], "product_description": "(1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and \n\n(2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.", "code_info": "(1) Double Female LL Adapter-special adapter to convert male fitting to a female luer lock - Lot numbers 11228606, 11227966, 11226655; and  (2) Double Male LL Adapter-special adapter to convert a female fitting to a male luer lock - Lot numbers 11227508, 11229885, 11230268, and 11231393.", "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. There was military/government distribution. \n\nForeign distribution was made to Canada, Australia, the Netherlands, and Spain.", "openfda": { "k_number": [ "K133624", "K951722", "K790407", "K831867", "K792073", "K792020", "K921898", "K851989", "K930888", "K830210", "K813502", "K855145", "K070710", "K885296", "K832897", "K823334", "K781680", "K811538", "K152980", "K052828", "K920977", "K902472", "K771668", "K812758", "K851988", "K833170", "K812883", "K172458", "K820579", "K900551", "K854596", "K871371", "K853996", "K801985", "K810661", "K802179", "K800705", "K842352", "K852652", "K951129", "K851486", "K813549", "K981745", "K840023", "K850898", "K843580", "K833096", "K101518", "K820202", "K904601", "K832907", "K904777", "K961404", "K091408", "K833271", "K821450", "K112203", "K802069", "K833095", "K830093", "K810637", "K841811", "K780128", "K881297", "K820457", "K810009", "K151040", "K161408", "K061573", "K801136", "K810735", "K820459", "K870301", "K101189", "K841788", "K831698", "K840274", "K780797", "K813464", "K820046", "K860681", "K820201", "K103715", "K841613", "K882118", "K810431", "K780127", "K043065", "K833094", "K800706", "K870356", "K983372", "K812884", "K841968", "K841960", "K832657", "K821416", "K123095", "K820676", "K163172", "K843273", "K813267", "K813266", "K884235", "K823286", "K803096", "K771361", "K822507", "K102033", "K854505", "K761325", "K862344", "K902453", "K120624", "K780477", "K833171", "K820677", "K820342", "K872596", "K831348", "K831506", "K833792", "K242909", "K820355", "K791636", "K884919", "K851987", "K811980", "K801048", "K813137", "K981747", "K851888", "K873168", "K821894", "K152472", "K801239", "K812530", "K864090", "K092644", "K883095", "K801138", "K221782", "K813053", "K820186", "K910764", "K840121", "K062342", "K921343" ], "registration_number": [ "", "2936999", "1713468", "3007048453", "3005580113", "3005012805", "1319639", "3013500228", "3018094310", "1054241", "1721504", "1218950", "1718873", "3015173212", "3013783488", "3011237704", "1649914", "3008496528", "9616088", "3012528160", "3006082230", "8020616", "3005941719", "3013596024", "3031233007", "1721676", "8043983", "8043969", "3033589330", "1423395", "1422634", "1055236", "3006891665", "2025816", "3004832480", "9616567", "3009106351", "3004111573", "3013319212", "3014541700", "9617594", "2221819", "1043214", "3012542015", "2246552", "8010042", "2648727", "3008693658", "3015225571", "9681377", "2032112", "3009077524", "3007603826", "1417592", "3008403546", "9610816", "3010421104", "1928237", "1061124", "3012536737", "3009001657", "2648045", "3017636737", "3015910259", "3005595283", "3007836437", "9612152", "3016701404", "1625425", "3002907620", "9610849", "3016618143", "1724474", "9615817", "1423537", "3006950086", "3003263092", "9616675", "3009156722", "3017987980", "3007307487", "1018233", "3015309643", "3032916632", "1526863", "3004605321", "3004519921", "3000126629" ], "fei_number": [ "", "2936999", "1713468", "3007048453", "3005580113", "3005012805", "3013500228", "3018094310", "1721504", "1218950", "1718873", "3016261803", "3003094851", "3015173212", "3013783488", "3011237704", "1000138054", "3002807111", "3008496528", "3012528160", "3006082230", "3013596024", "3031233007", "1721676", "3033589330", "3006891665", "3003076831", "2025816", "3004832480", "3009106351", "3002807167", "3004111573", "3013319212", "3014541700", "2221819", "3002806476", "1000512168", "3001236905", "3004050362", "1043214", "3012542015", "1000112877", "2246552", "1000112968", "2648727", "3008693658", "3015225571", "3009077524", "3007603826", "1000514656", "1417592", "3008403546", "3010421104", "1000300598", "1928237", "3012536737", "3009001657", "2648045", "3017636737", "3015910259", "3005595283", "3007836437", "3016701404", "1625425", "3002806901", "3002907620", "3016618143", "3005846326", "3003105967", "3006950086", "3000717925", "3002807391", "3003263092", "3002808128", "3002963732", "3009156722", "3017987980", "3007307487", "1018233", "3015309643", "3003081151", "3032916632", "1526863", "3002902735", "3004605321", "3000126629", "3001665800", "3003807466" ], "device_name": "Transducer, Blood-Pressure, Extravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2850", "device_class": "2" } } ] }