{ "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": "175981", "product_res_number": "Z-0293-2020", "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": [ "K771701" ], "product_description": "(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx;\n\n(2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300, 2 clamps per package, 5 packages/ shelf box, 10 shelf boxes/case (for a total of 50/2-clamp packages/case), Sterile, Rx;\n\n(3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301, 2 clamps per package, 6 packages/box, 50 boxes/case, Sterile, Rx; and\n\n(4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401, 2 clamps per package, 5 packages/box, 50 boxes/case.\n\nThe firm name on the label is Argon Medical Devices, Inc., Athens, TX.", "code_info": "(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200 - Lot number 11230432;  (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Straight, REF 046-1-300 - Lot numbers 11226690 and 11231581  (3) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Medium Angled, REF 046-1-301 - Lot number 11227669;  (4) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Large Angled, REF 046-1-401 - Lot numbers 11228371 and 11230677.", "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" } } ] }