{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "198829", "product_res_number": "Z-1345-2023", "event_date_initiated": "2023-03-01", "event_date_posted": "2023-04-05", "recall_status": "Open, Classified", "res_event_number": "91775", "product_code": "DTZ", "k_numbers": [ "K062381" ], "product_description": "CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30", "code_info": "UDI-DI: (01)00699753450134;\nLot Number: 2M10", "firm_fei_number": "3000204839", "recalling_firm": "Terumo Cardiovascular Systems Corporation", "address_1": "125 Blue Ball Rd", "city": "Elkton", "state": "MD", "postal_code": "21921-5315", "additional_info_contact": "Terumo CVS Customer Service\n800-521-2818", "reason_for_recall": "Some Capiox NX, RX and FX Oxygenators may contain an arterial thermistor component that is improperly bonded to the oxygenator port. This may result in a leak at the point where the arterial thermistor is improperly bonded to the oxygenator port.", "root_cause_description": "Process control", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 3/1/23 was sent to customers.\n\nRECOMMENDED ACTIONS\nTerumo CVS advises users to remove all affected product from inventory and return unused product to Terumo CVS following the instructions provided in this notice.\n\nTerumo CVS will credit the user s accounts for returned, unused products.\n\nAFFECTED POPULATION\nThe affected population is all patients on which an impacted Capiox NX, RX or FX Oxygenator is used.\n\nCUSTOMER INSTRUCTIONS -\n Review this Medical Device Recall notice and ensure that all users receive notice of this issue.\n Refer to the Customer Response Form to identify your product inventory that is subject to this action.\n Confirm receipt of this communication by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form. Please return the Customer Response Form even if you no longer have the affected product in inventory.\n If the affected product has been distributed to another user or location, please forward a copy of the notice as needed.\n Terumo CVS will issue a Return Goods Authorization upon receipt of the Customer Response Form.\n Return all affected products to Terumo CVS.\n\nQUESTIONS?\nWe encourage you to contact Terumo CVS with any questions or concerns:\n Terumo CVS Customer Service: 1.800.521.2818 Monday Friday, 8 a.m. 6 p.m. ET\n Terumo Recall Fax: 443-993-5738 or emailing 4439935738@efax.com\n Terumo Recall Email: TCVSCustomerResponseElkton@terumomedical.com", "product_quantity": "1412 units", "distribution_pattern": "US Nationwide. Belgium, Canada, Costa Rica, Thailand.", "openfda": { "k_number": [ "K833670", "K013038", "K103191", "K132829", "K100278", "K172626", "K122844", "K951247", "K242503", "K984271", "K811004", "K941225", "K072091", "K803231", "K893704", "K892641", "K101153", "K812660", "K030264", "K093522", "K863249", "K071774", "K772237", "K150489", "K040210", "K790406", "K004001", "K191029", "K071572", "K894970", "K802328", "K781223", "K223161", "K964967", "K830639", "K961530", "K896671", "K892664", "K031223", "K200109", "K151713", "K822803", "K925075", "K162896", "K823456", "K083021", "K073380", "K143073", "K934292", "K031903", "K962667", "K901253", "K926226", "K961734", "K960074", "K963518", "K874841", "K923272", "K212341", "K000430", "K844901", "K932252", "K823273", "K061628", "K130209", "K090449", "K991737", "K903436", "K974085", "K231652", "K851035", "K823125", "K201916", "K051997", "K133261", "K941653", "K980974", "K240666", "K941473", "K883054", "K821216", "K122254", "K912082", "K013480", "K992559", "K901249", "K062381", "K912920", "K090450", "K964043", "K772284", "K120185", "K897068", "K831895", "K872133", "K864235", "K050447", "K231414", "K974812", "K123314", "K151389", "K780078", "K130493", "K020351", "K092895", "K912078", "K803003", "K933586", "K121909", "K922799", "K200683", "K142784", "K894103", "K250821", "K925076", "K760824", "K253838", "K180950", "K230640", "K183511", "K962641", "K823343", "K891230", "K802970", "K140774", "K920889", "K830327", "K202206", "K141492", "K001021", "K833518", "K953976", "K061031", "K831705", "K100645", "K790356", "K183490", "K843956", "K211495", "K853080", "K890808", "K833078", "K113626", "K203424", "K895393", "K781842", "K121229", "K813255", "K140177", "K102464", "K153213", "K961000", "K973760", "K082117", "K010478", "K014080", "K860673", "K231982", "K862918", "K926467", "K912655", "K112360", "K023381", "K863515", "K896978", "K861641", "K810532", "K911227", "K842908", "K854045", "K833253", "K831122", "K891687", "K180448", "K082403", "K013915", "K121536", "K033323", "K222297", "K010443", "K231773", "K993772", "K153140", "K130359", "K901250", "K880021", "K240934", "K860539", "K990103", "K841476", "K130433", "K162016", "K090689", "K810470", "K953835", "K810505", "K150267", "K861177", "K153295", "K191444", "K043323", "K931444", "K843955", "K802720", "K971877", "K172071", "K071494", "K992910", "K901624", "K802719", "K022450", "K925626", "K831894", "K022115", "K090511", "K151791", "K203111", "K850630", "K894630", "K130520", "K792039", "K853251", "K190690", "K122827", "K970463", "K882892", "K912079", "K072362", "K893207", "K172984", "K191246", "K872107", "K140181", "K922933", "K883053", "K020997", "K241352", "K894826", "K080708", "K954850", "K102109", "K910107", "K130333", "K873923", "K991452", "K863476", "K201642", "K821477", "K801240", "K895632", "K800555", "K130280", "K000255", "K202510" ], "registration_number": [ "3010155661", "3005941719", "3011554160", "3008307705", "8010762", "1319639", "3044156918", "3015136750", "1928237", "9617601", "1625519", "3045892899", "3002806603", "2184009", "1643817", "2011171", "3010163695", "1124841", "3002807090", "3021599320", "3019807891", "3014990448", "3013267343", "3003752502", "3009507273", "1218444", "9680841", "8010026", "3030125051", "2528981", "9681834", "1220648", "3016746283", "2916596" ], "fei_number": [ "3010155661", "3011554160", "3008307705", "3044156918", "2828", "3015136750", "1928237", "1625519", "3045892899", "3009649876", "3002806603", "3000204839", "1000116158", "1643817", "2011171", "3010163695", "1000138054", "3021599320", "3002534070", "3005426550", "3019807891", "3014990448", "3013267343", "3002807111", "3003752502", "3009507273", "1218444", "3030125051", "2528981", "3006003617", "1220648", "3016746283", "2916596", "3002808327" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }