{ "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": "204714", "product_res_number": "Z-0621-2024", "event_date_initiated": "2023-11-01", "event_date_posted": "2023-12-28", "recall_status": "Open, Classified", "res_event_number": "93553", "product_code": "CAC", "k_numbers": [ "K043140" ], "product_description": "Atrium Oasis Drain Single W / AC, Part No. 3600-100", "code_info": "UDI-DI 00650862110012\nLots 492065 and 492075", "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": "Jessica Minaya\n603-880-1433", "reason_for_recall": "A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.", "root_cause_description": "Nonconforming Material/Component", "action": "On November 1, 2023, the firm issued URGENT MEDICAL DEVICE - Removal letters to affected customers.\n\nCustomers were instructed to remove any product from the affected lots from areas of use. Customers with affected product are entitled to a replacement at no cost to their facility. Customers will receive replacements upon their acknowledgement that they have affected product for return.\n\nDistributors should forward recall documentation to affected customers.\n\nCustomers with questions may contact their Atrium/Getinge representative or call the Atrium/Getinge Customer Support at (603) 880-1433 (press option 1), Monday through Friday, 9AM-6PM Eastern Time Zone.", "product_quantity": "835 cases total (6 units/case)", "distribution_pattern": "Domestic distribution nationwide. No foreign distribution.", "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" } } ] }