{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "123492", "product_res_number": "Z-0736-2014", "event_date_initiated": "2013-11-19", "event_date_posted": "2014-01-14", "recall_status": "Terminated", "event_date_terminated": "2015-06-11", "res_event_number": "66788", "product_code": "CAC", "k_numbers": [ "K043140", "K043582" ], "product_description": "Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock and in-line connectors Sterile fluid path packaging \nProduct Code: 2050-070.\n\nTo evacuate air and/or fluid from the chest cavity or mediastinum.", "code_info": "Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers).  To evacuate air and/or fluid from the chest cavity or mediastinum.", "firm_fei_number": "3011175548", "recalling_firm": "Atrium Medical Corporation", "address_1": "5 Wentworth Dr", "city": "Hudson", "state": "NH", "postal_code": "03051-4929", "additional_info_contact": "Kenneth Collins \n603-880-1433", "reason_for_recall": "Chest Drain tubing of of the ATS Blood recovery may leak or disconnect", "root_cause_description": "Device Design", "action": "Atrium Medical issued notification letters to direct consignees by UPS next day on 19 November 2013, and indirect consignees (distributors customers) by UPS next day or USPS priority (for customers with a PO Box) on 27 November 2013. The Letter explain the issue and the steps that should be taken. The customer will be offered replacement with unaffected product or credit. The firm describes Procedures for Emergency Use. The firm identifies potential product substitutions. These products are the same drainage product without the auto-transfusion line.\nInternational Distributors. International distributors provided with the Recall Authorization' package and the customer letter.\nAccounts are requested to complete the Recall Reply Form acknowledging receipt of the notification.\nContact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm.", "product_quantity": "624 units", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.", "openfda": { "k_number": [ "K221722", "K022348", "K831557", "K812355", "K031554", "K915130", "K912610", "K974897", "K862684", "K112245", "K897126", "K932890", "K883934", "K931899", "K160735", "K897127", "K022167", "K871258", "K231782", "K882757", "K830735", "K900299", "K902759", "K881421", "K043140", "K893402", "K875023", "K781552", "K871847", "K940519", "K881350", "K925827", "K103202", "K920618", "K843821", "K221483", "K162423", "K992723", "K120586", "K952224", "K953118", "K991986", "K942844", "K854301", "K920273", "K881631", "K791891", "K960734", "K910211", "K913247", "K940678", "K831849", "K864374", "K892819", "K020647", "K041525", "K911656", "K802674", "K955010", "K122262", "K881683", "K873807", "K926338", "K912609", "K932093", "K811228", "K960006", "K933960", "K193361", "K895297", "K901401", "K014187", "K140197", "K902671", "K931552", "K871568", "K903392", "K120953", "K101586", "K970857", "K890171", "K924894", "K913177", "K984233", "K892857", "K060482", "K883082", "K872590", "K962475", "K931106", "K781550", "K014083", "K912019", "K914119", "K872162", "K210862", "K973378", "K942791", "K842610", "K896857", "K904474", "K910991", "K973627", "K904888", "K043127", "K872160", "K210176", "K884564", "K872927", "K012406", "K904041", "K012178", "K904164", "K201305", "K896858", "K982241", "K131553", "K781553", "K772196", "K963850", "K893218", "K951592", "K180831", "K900325", "K901232", "K970714", "K893578", "K972894", "K904515", "K945775", "K781551", "K964070", "K881129", "K852425", "K772280", "K872814", "K210089", "K923016", "K894668", "K963759", "K913181", "K140205", "K851024", "K053000", "K852736", "K871624", "K110782", "K240426", "K884844", "K101907", "K962689", "K852178", "K892443", "K910238", "K913773", "K192368", "K902059", "K241236", "K900483", "K912956", "K914053", "K860306", "K240584", "K883663", "K812292", "K181954", "K982755", "K982712", "K963758", "K982660", "K936220", "K902713", "K093535", "K872158", "K983022", "K944232", "K881692", "K880162", "K901138", "K963098", "K883058", "K861677", "K894294", "K893394", "K904794", "K993581", "K024097", "K971274", "K082923", "K982650", "K022489", "K160197", "K130043", "K913684", "K933625" ], "registration_number": [ "2029015", "3010009632", "9680425", "9617601", "3019807891", "3008810357", "2184009", "1836518", "3006654680", "3031823122", "1526534", "1219343", "2029275", "3010041511", "8022032", "1424263", "3005012805", "1928237", "9611109", "1220477", "3010413216", "3011554160", "1724474", "1718850", "9680841", "3004593495", "3015219237", "1064858", "3011137372", "3011175548", "3010084488", "3011773324", "3020347218", "9612051", "2528981", "3010273872", "3007923088", "3010220595", "9617787", "9681630", "3009380063", "2032112", "3004111573", "9615908", "3004142400", "3004634229", "3011270181", "3004365956", "2011171", "8043817", "9680143", "3016994551", "3004548776", "3044156918", "3010291427" ], "fei_number": [ "3010009632", "3003282181", "3001717360", "3007596547", "3003094851", "3008810357", "3019807891", "3002808267", "3003094575", "3006654680", "1000116158", "1526534", "1219343", "3010041511", "3005012805", "3003015552", "1928237", "3002806457", "3002807308", "3010413216", "1220477", "3011554160", "3008397795", "3002808845", "1000306431", "1718850", "3004593495", "3015219237", "3003076831", "3011175548", "3010084488", "3011773324", "3020347218", "3005426550", "2528981", "3002534070", "3010273872", "3003327833", "3007923088", "3010220595", "3005747797", "3009380063", "1000160458", "3004111573", "3004142400", "3004634229", "3011270181", "3004365956", "2011171", "3031823122", "3016994551", "3003261020", "3004548776", "3044156918", "3010291427" ], "device_name": "Apparatus, Autotransfusion", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5830", "device_class": "2" } } ] }