{ "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": "175976", "product_res_number": "Z-0290-2020", "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": [ "K780271" ], "product_description": "(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx;\n\n(2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A, 25/box, Sterile, Rx;\n\n(3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A, 25/box, Sterile, Rx; \n\n(4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A, Sterile, Rx; \n\n(5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A, 25/box, Sterile, Rx; and\n\n(6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590, 25/box, Sterile, Rx.\n\nThe firm name on the labels is Argon Medical Devices, Inc., Athens, TX.", "code_info": "(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A-Lot numbers 11226656 and 11228887;  (2) Argon Medical Devices Stopcocks, 1-Way w/Male Luer Lock, REF 041216000A - Lot numbers 11226187, 11229619, and 11227967;  (3) Argon Medical Devices Stopcocks, Double 4-Way Stopcock w/Male Luer Lock, REF 041220001A - Lot numbers 11228888, 11230598;  (4) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Rotating Male Luer Lock, REF 041240002A - Lot number 11228245;  (5) Argon Medical Devices Stopcocks, North Carolina Baptist Hospital, Winston-Salem, NC, REF 042597300A - Lot number 11232206; and  (6) Argon Medical Devices 3 Way Stopcock w/Rotating Adapter (1050psi), REF 196590 - Lot numbers 11229800 and 11232485.", "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": [ "K841613", "K921343", "K801048", "K831867", "K921898", "K101518", "K810637", "K910764", "K820186", "K811980", "K052828", "K951722", "K103715", "K873168", "K820046", "K163172", "K823334", "K870301", "K812883", "K855145", "K112203", "K780128", "K781680", "K802179", "K152472", "K813502", "K812758", "K981747", "K101189", "K852652", "K904777", "K152980", "K801138", "K820342", "K821450", "K043065", "K833792", "K820459", "K833094", "K802069", "K780797", "K810009", "K872596", "K123095", "K803096", "K771361", "K920977", "K820676", "K161408", "K841811", "K062342", "K832897", "K851486", "K930888", "K840121", "K902472", "K092644", "K813464", "K792020", "K813267", "K853996", "K900551", "K172458", "K851987", "K151040", "K821416", "K883095", "K831698", "K871371", "K832657", "K102033", "K821894", "K070710", "K813053", "K862344", "K801985", "K120624", "K811538", "K881297", "K780477", "K884919", "K983372", "K851888", "K812530", "K884235", "K864090", "K841788", "K820457", "K882118", "K823286", "K761325", "K830093", "K832907", "K840023", "K091408", "K810735", "K885296", "K850898", "K833271", "K810431", "K061573", "K812884", "K800705", "K833095", "K133624", "K820202", "K981745", "K221782", "K831506", "K820579", "K813137", "K951129", "K810661", "K813549", "K833170", "K854505", "K790407", "K833096", "K843273", "K833171", "K792073", "K780127", "K822507", "K830210", "K851988", "K870356", "K820355", "K801136", "K831348", "K854596", "K800706", "K841960", "K801239", "K860681", "K904601", "K902453", "K840274", "K820201", "K771668", "K820677", "K841968", "K851989", "K843580", "K791636", "K961404", "K842352", "K242909", "K813266" ], "registration_number": [ "", "3017987980", "3005595283", "1649914", "3006891665", "3011237704", "1417592", "3013783488", "1713468", "3012542015", "2025816", "3008496528", "3016701404", "3006950086", "3007048453", "9610849", "8043983", "3007603826", "3009077524", "3014541700", "1625425", "2221819", "9610816", "3009001657", "1718873", "3018094310", "2032112", "3004519921", "3009156722", "2648727", "3003263092", "3016618143", "3004111573", "2936999", "3013500228", "3015309643", "1218950", "1423395", "3013596024", "9616088", "1724474", "3013319212", "3017636737", "3005941719", "3009106351", "9616675", "8010042", "9615817", "3010421104", "2648045", "8020616", "3004832480", "3008693658", "9612152", "1422634", "3000126629", "3002907620", "3032916632", "1423537", "1721504", "1043214", "9617594", "3012528160", "1721676", "3007836437", "3007307487", "3015173212", "1061124", "3008403546", "1018233", "1055236", "3004605321", "3033589330", "3012536737", "8043969", "3015910259", "1526863", "3005580113", "2246552", "3006082230", "9616567", "3015225571", "1928237", "1319639", "3031233007", "1054241", "3005012805", "9681377" ], "fei_number": [ "", "3017987980", "3005595283", "1000138054", "3002902735", "3001236905", "3006891665", "3011237704", "3004050362", "1417592", "3013783488", "1713468", "3012542015", "2025816", "3002807391", "3008496528", "1000514656", "3016701404", "3006950086", "3007048453", "3005846326", "3007603826", "3009077524", "3014541700", "3002807111", "3002807167", "1625425", "2221819", "3003076831", "3009001657", "1718873", "3018094310", "1000300598", "3009156722", "2648727", "3003081151", "3003263092", "3016618143", "3004111573", "2936999", "3013500228", "3015309643", "3003105967", "1218950", "3013596024", "3002808128", "3013319212", "3002806476", "3017636737", "3009106351", "3010421104", "3001665800", "2648045", "3004832480", "3008693658", "3000126629", "3002907620", "3032916632", "1721504", "1043214", "1000112968", "3002963732", "3012528160", "1721676", "3016261803", "3007836437", "3007307487", "1000512168", "3015173212", "3000717925", "3008403546", "1018233", "3004605321", "1000112877", "3002806901", "3033589330", "3012536737", "3015910259", "1526863", "3005580113", "2246552", "3006082230", "3015225571", "3003094851", "1928237", "3031233007", "3005012805", "3003807466" ], "device_name": "Transducer, Blood-Pressure, Extravascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.2850", "device_class": "2" } } ] }