{ "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": "204036", "product_res_number": "Z-0486-2024", "event_date_initiated": "2023-09-05", "event_date_posted": "2023-12-02", "recall_status": "Open, Classified", "res_event_number": "93343", "product_code": "CAC", "k_numbers": [ "K043582" ], "product_description": "Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3650-100, DRAIN, OASIS BRU W/AC, 3650 ATS BLOOD RECOVERY", "code_info": "UDI-DI: 20650862113017. \nLots: 461817, 467572, 467572, 468617, 468855, 467191, 467849, 469401, 479253.", "firm_fei_number": "3011175548", "recalling_firm": "Atrium Medical Corporation", "address_1": "40 Continental Blvd", "city": "Merrimack", "state": "NH", "postal_code": "03054-4332", "additional_info_contact": "603-880-1433", "reason_for_recall": "Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.", "root_cause_description": "Labeling mix-ups", "action": "The recall notification was issued via Fed-Ex and email on October 5, 2023. It requests (1) immediate quarantine and return of all affected product inventory on hand. (2) for any product further distributed, notify customers that have received affected product to remove the affected devices from use and return them. Questions may be addressed to your Getinge representative or call Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).", "distribution_pattern": "US: VA", "openfda": { "k_number": [ "K854301", "K972894", "K894668", "K955010", "K914053", "K890171", "K201305", "K861677", "K944232", "K993581", "K852178", "K895297", "K881350", "K900483", "K024097", "K913181", "K160735", "K940678", "K923016", "K101907", "K991986", "K893218", "K101586", "K913177", "K910238", "K864374", "K875023", "K912609", "K912610", "K901138", "K781553", "K893402", "K982241", "K893578", "K960734", "K933625", "K893394", "K902059", "K240584", "K974897", "K960006", "K940519", "K904888", "K210089", "K831849", "K903392", "K925827", "K852425", "K953118", "K781550", "K992723", "K871847", "K933960", "K871568", "K873807", "K920618", "K860306", "K982660", "K883934", "K882757", "K963098", "K900299", "K811228", "K830735", "K872927", "K210862", "K031554", "K912956", "K130043", "K970714", "K082923", "K012178", "K881421", "K872158", "K140205", "K852736", "K842610", "K022489", "K894294", "K812292", "K945775", "K880162", "K931899", "K984233", "K881692", "K982712", "K931106", "K884844", "K952224", "K904515", "K936220", "K911656", "K843821", "K926338", "K871624", "K772196", "K924894", "K180831", "K781551", "K871258", "K904794", "K872814", "K881631", "K963759", "K904041", "K160197", "K902713", "K883663", "K781552", "K022348", "K901232", "K963850", "K872162", "K221722", "K883082", "K897126", "K812355", "K970857", "K862684", "K140197", "K912019", "K851024", "K802674", "K914119", "K060482", "K883058", "K892819", "K896858", "K913247", "K772280", "K982650", "K192368", "K892857", "K110782", "K240426", "K902759", "K983022", "K910211", "K012406", "K931552", "K131553", "K043140", "K791891", "K122262", "K904164", "K910991", "K181954", "K897127", "K103202", "K896857", "K973627", "K020647", "K913773", "K881129", "K902671", "K881683", "K964070", "K241236", "K043127", "K932890", "K093535", "K901401", "K120586", "K210176", "K962475", "K932093", "K221483", "K915130", "K900325", "K053000", "K951592", "K942844", "K892443", "K120953", "K973378", "K014187", "K942791", "K982755", "K884564", "K112245", "K193361", "K162423", "K872160", "K014083", "K831557", "K962689", "K963758", "K971274", "K022167", "K872590", "K231782", "K041525", "K913684", "K920273", "K904474" ], "registration_number": [ "9680841", "9612051", "2011171", "1526534", "2029015", "3011175548", "3019807891", "1718850", "3004548776", "3031823122", "3004142400", "2029275", "2032112", "3011270181", "1219343", "9680425", "3004111573", "9617601", "3020347218", "3004634229", "3010220595", "3004365956", "9681630", "9615908", "3011554160", "8043817", "3010084488", "3016994551", "1928237", "3006654680", "2184009", "1836518", "1064858", "1424263", "3010413216", "3007923088", "3010273872", "8022032", "1220477", "3004593495", "3010041511", "1724474", "9680143", "3005012805", "3008810357", "9617787", "3010291427", "3011137372", "3009380063", "2528981", "3010009632", "3011773324", "9611109", "3015219237", "3044156918" ], "fei_number": [ "1000160458", "1000116158", "2011171", "1526534", "3005747797", "3011175548", "3003076831", "3019807891", "3001717360", "3007596547", "1718850", "3004548776", "3031823122", "3002807308", "3003282181", "3004142400", "3008397795", "1000306431", "3011270181", "1219343", "3004111573", "3004634229", "3020347218", "3010220595", "3004365956", "3002534070", "3003094575", "3011554160", "3005426550", "3002808845", "3010084488", "3016994551", "3003094851", "3006654680", "3003015552", "1928237", "3002808267", "3010413216", "3003261020", "3002806457", "3007923088", "3010273872", "1220477", "3004593495", "3003327833", "3010041511", "3005012805", "3008810357", "3010291427", "3009380063", "2528981", "3010009632", "3011773324", "3015219237", "3044156918" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ] }