{ "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": "105511", "product_res_number": "Z-0842-2012", "event_date_initiated": "2010-06-28", "event_date_posted": "2012-01-24", "recall_status": "Terminated", "event_date_terminated": "2012-02-29", "res_event_number": "60475", "product_code": "DTZ", "k_numbers": [ "K993772" ], "product_description": "Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures. The integral heat exchanger is used to warm or cool the blood or perfusion fluid and the detachable hardshell reservoir is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal.", "code_info": "Product code 3CXSX18RX, Lot # HF22", "firm_fei_number": "3000204839", "recalling_firm": "Terumo Cardiovascular Corporation", "address_1": "125 Blue Ball Rd", "city": "Elkton", "state": "MD", "postal_code": "21921-5315", "additional_info_contact": "Michael Silvestri\n410-392-7102", "reason_for_recall": "Complaints were received of expired X-coated Capiox SX18 Hollow Fiber oxygenators.", "root_cause_description": "Employee error", "action": "All customers were contacted by telephone between 6/28/10 and 7/2/10. The manufacturer mailed \"Urgent Medical Device Removal \" letters to customers on 01/16/12 with receipt confirmation requested. Customers were informed that expired product had been shipped. Use of expired product was not recommended and product return was requested for refund. Contact Terumo CVS Customer Service 1-800-521-2818 for questions.", "product_quantity": "16 units", "distribution_pattern": "Nationwide Distribution including states of: WI, MO,and KY.", "openfda": { "k_number": [ "K831122", "K242503", "K990103", "K861641", "K894970", "K223161", "K910107", "K241352", "K912655", "K790356", "K022115", "K140177", "K961530", "K863249", "K872133", "K802328", "K810470", "K811004", "K843955", "K772237", "K102464", "K974085", "K862918", "K191444", "K802719", "K202510", "K103191", "K925626", "K823125", "K802720", "K231414", "K901253", "K050447", "K061628", "K891230", "K932252", "K843956", "K133261", "K810532", "K200683", "K212341", "K964043", "K893704", "K183490", "K872107", "K897068", "K923272", "K833518", "K090450", "K844901", "K882892", "K071494", "K873923", "K772284", "K823273", "K821216", "K841476", "K202206", "K964967", "K092895", "K162016", "K970463", "K810505", "K240934", "K010443", "K172984", "K851035", "K961000", "K122844", "K203111", "K812660", "K073380", "K831894", "K892664", "K030264", "K864235", "K153140", "K962667", "K853251", "K850630", "K222297", "K004001", "K963518", "K191246", "K890808", "K072091", "K803231", "K971877", "K143073", "K991452", "K842908", "K861177", "K101153", "K230640", "K201916", "K853080", "K951247", "K823343", "K760824", "K013480", "K201642", "K901624", "K112360", "K892641", "K926467", "K984271", "K121909", "K033323", "K051997", "K922933", "K781223", "K132829", "K072362", "K013038", "K191029", "K151389", "K874841", "K880021", "K833670", "K153213", "K013915", "K860539", "K231982", "K974812", "K891687", "K140181", "K150489", "K162896", "K962641", "K180950", "K896978", "K040210", "K043323", "K941653", "K151791", "K071774", "K180448", "K903436", "K883054", "K000255", "K933586", "K061031", "K973760", "K893207", "K901250", "K922799", "K093522", "K831895", "K953835", "K130359", "K001021", "K953976", "K912078", "K022450", "K911227", "K153295", "K250821", "K203424", "K800555", "K253838", "K895393", "K960074", "K200109", "K954850", "K031903", "K150267", "K830639", "K100278", "K926226", "K151713", "K102109", "K122827", "K860673", "K140774", "K231652", "K142784", "K240666", "K130520", "K895632", "K992559", "K130280", "K113626", "K896671", "K130209", "K172071", "K083021", "K121536", "K020351", "K062381", "K020997", "K912079", "K010478", "K992910", "K912920", "K823456", "K090511", "K802970", "K090449", "K790406", "K920889", "K912082", "K031223", "K172626", "K894103", "K231773", "K781842", "K190690", "K980974", "K831705", "K090689", "K854045", "K894630", "K830327", "K000430", "K120185", "K863476", "K961734", "K833078", "K183511", "K082117", "K813255", "K014080", "K894826", "K780078", "K803003", "K211495", "K130493", "K925076", "K082403", "K822803", "K934292", "K821477", "K863515", "K991737", "K071572", "K883053", "K141492", "K792039", "K130433", "K901249", "K931444", "K925075", "K941225", "K130333", "K122254", "K080708", "K833253", "K941473", "K121229", "K023381", "K100645", "K123314", "K801240", "K993772" ], "registration_number": [ "9680841", "3015136750", "2011171", "3019807891", "3010155661", "3014990448", "3010163695", "3009507273", "1625519", "1643817", "9617601", "3030125051", "3011554160", "2916596", "1928237", "8010026", "3013267343", "2184009", "1319639", "9681834", "3002807090", "1220648", "3008307705", "3003752502", "3002806603", "1218444", "8010762", "2528981", "3016746283", "3021599320", "3045892899", "1124841", "3005941719", "3044156918" ], "fei_number": [ "1000116158", "1000138054", "3015136750", "2011171", "3019807891", "3010155661", "3014990448", "3000204839", "3010163695", "3009507273", "1625519", "1643817", "3030125051", "3002534070", "2828", "3011554160", "3005426550", "2916596", "1928237", "3013267343", "3009649876", "3002808327", "1220648", "3006003617", "3008307705", "3003752502", "3002806603", "1218444", "2528981", "3016746283", "3021599320", "3045892899", "3002807111", "3044156918" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }