{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "203544", "product_res_number": "Z-0317-2024", "event_date_initiated": "2023-09-18", "event_date_posted": "2023-11-16", "recall_status": "Open, Classified", "res_event_number": "93149", "product_code": "CAC", "k_numbers": [ "K043140", "K201305" ], "product_description": "Oasis Dry Suction Water Seal Chest Drains (Oasis):\n(1)3600-100 DRAIN, OASIS SINGLE W/AC;\n(2)3612-100 DRAIN, OASIS PEDI A/C;\n(3)3650-100 DRAIN, OASIS BRU W/AC;", "code_info": "UDI-DI: \n(1)3600-100 DRAIN, OASIS SINGLE W/AC 20650862110016;\n(2)3612-100 DRAIN, OASIS PEDI A/C 20650862111013;\n(3) 3650-100 DRAIN, OASIS BRU W/AC 20650862113017\n\nAll lots within labeled product expiry\nManufacturing Dates: Any product manufactured on and after July 21, 2020\nDistribution Dates: Any product shipped on and after August 6, 2020", "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": "SAME\n603-880-1433", "reason_for_recall": "Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of\ncatheter(s) and patient tube connections with single collection chamber chest drains", "root_cause_description": "Error in labeling", "action": "UPDATE: April 2024. Getinge issued letter Getinge Thoracic Drainage Labeling Updates:\nNew Instructions for Use Precaution for Oasis and Express Chest Drains to existing customers April 17, 2024 (US) and April 23, 2024 (OUS).\nAs a result, inventory will be a mix of the current IFU and new IFU with the updated precaution statement until the current IFU-containing products are depleted.\nReminder: In September 2023, Getinge initiated Medical Device Correction 3011175548-08/18/2023-001-C which requested your facility to post a copy of the Notice on Page 4 of the notification in all inventory locations where the devices are stored. Since the updated IFU now contains this new Precaution, the Page 4 Notice may be removed from all inventory locations once all affected product with expiry labeled March 7th, 2024 and earlier has been depleted. Please contact your Getinge Inside Sales Representative should you need an electronic copy of the new Instructions for Use.\n\n\n\nAtrium/Getinge issued URGENT MEDICAL DEVICE Correction letter on September 18, 2023 via FedEx 2 day delivery on or before, September 20, 2023. Letter states reason for recall, health risk and action to take:\nfacility can continue use of the device. No devices need to be returned.\n\" Please ensure that all Atrium Ocean, Oasis, or Express Single Collection Chest Drain\nusers at your facility are aware of this Safety Notice and post a copy of the Notice on\nPage 4 in all inventory locations within your facility where the devices are stored\nNotification of the release of the updated IFU containing the new Precaution will\nbe communicated to all customers upon release, including reminder the Notice on\nPage 4 may be removed upon the facility s receipt of product with the updated IFU.\n\" Please forward this information to all current and potential Atrium Ocean, Oasis, or\nExpress Single Collection Chest Drain users within your hospital / facility.\n\" If you are a distributor who has shipped any affected products to custom", "product_quantity": "471037 cases US; 638 case OUS", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, \nBahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic\nEcuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, \nItaly, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, \nMalta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, \nPeru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, \nSlovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand\nTunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.", "openfda": { "k_number": [ "K955010", "K897127", "K881692", "K893394", "K862684", "K160197", "K902713", "K020647", "K942791", "K893218", "K883934", "K910238", "K963850", "K900299", "K022348", "K781550", "K892443", "K022167", "K012406", "K852178", "K896858", "K963758", "K781551", "K973627", "K884564", "K982755", "K973378", "K904515", "K953118", "K103202", "K012178", "K831849", "K231782", "K894294", "K923016", "K913177", "K883058", 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"K933625", "K851024", "K902671", "K014187", "K915130", "K210089", "K240584", "K221722", "K883663", "K932890", "K192368", "K872814", "K120586", "K924894", "K913247", "K960006", "K904164", "K880162", "K893578", "K944232", "K901401", "K913773", "K883082", "K241236", "K926338", "K181954", "K772280", "K093535", "K881683", "K900325", "K872590", "K872158", "K881421", "K043140", "K781553", "K903392", "K802674", "K940678", "K910991", "K860306", "K936220", "K982241", "K931899", "K901138", "K022489", "K904474", "K162423", "K925827", "K912019", "K130043", "K914119", "K974897", "K904794", "K831557", "K101907", "K982712", "K900483", "K962689", "K864374", "K811228", "K060482", "K963759", "K131553", "K920618", "K884844", "K871624", "K861677" ], "registration_number": [ "3010291427", "9611109", "2029275", "1064858", "9680425", "3016994551", "1220477", "1526534", "3007923088", "3031823122", "3005012805", "3004634229", "3044156918", "2011171", "9612051", "3006654680", "3010273872", "3011270181", "9615908", "3011137372", "3010084488", "3020347218", "8022032", "1724474", "3008810357", "3009380063", "3004142400", "3010041511", "2032112", "2184009", "3004548776", "9681630", "3011554160", "3015219237", "3010009632", "3011773324", "3010220595", "1219343", "1718850", "2029015", "2528981", "9680143", "9680841", "1836518", "3010413216", "3011175548", "3004365956", "9617787", "3019807891", "8043817", "3004593495", "1928237", "3004111573", "1424263", "9617601" ], "fei_number": [ "3010291427", "3003094575", "3016994551", "3002534070", "1220477", "3003076831", "1526534", "3003015552", "3007923088", "3031823122", "3005426550", "3005012805", "1000160458", "3004634229", "3044156918", "2011171", "3006654680", "3002807308", "3003261020", "3010273872", "3011270181", "3010084488", "3020347218", "3003282181", "3008810357", "3009380063", "3004142400", "3002808845", "3010041511", "3004548776", "3011554160", "1000306431", "3015219237", "3010009632", "3011773324", "3010220595", "1219343", "1718850", "3007596547", "2528981", "3002808267", "3005747797", "3010413216", "3011175548", "3004365956", "3001717360", "3019807891", "3008397795", "3004593495", "1928237", "3003094851", "3003327833", "3002806457", "1000116158", "3004111573" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ] }