{ "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": "151289", "product_res_number": "Z-0826-2017", "event_date_initiated": "2016-11-16", "event_date_posted": "2016-12-20", "recall_status": "Terminated", "event_date_terminated": "2017-08-01", "res_event_number": "75795", "product_code": "DTZ", "k_numbers": [ "K132972", "K142784", "K924529" ], "product_description": "Affinity Fusion\" Oxygenator with Integrated Arterial Filter,\nAffinity Fusion cardiotomy/Venous Reservoir,\nPerfusion Tubing Packs\n\nThe Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.", "code_info": "Product UPN/GTIN\tLot Number\tProduct 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"firm_fei_number": "3001504994", "recalling_firm": "Medtronic Inc", "address_1": "710 Medtronic Pkwy NE", "city": "Minneapolis", "state": "MN", "postal_code": "55432-5603", "additional_info_contact": "Medtronic Representative\n800-633-8766", "reason_for_recall": "Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion Oxygenators with Balance1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.", "root_cause_description": "Process control", "action": "The firm, Medtronic, sent an \"Urgent Medical Device Recall\" letter dated November 2016 to its Consignees on 11/16/2016. The letter was addressed to Risk Manager or Healthcare Professional. The letter described the problem and the product involved in the recall and actions to be taken. The consignees were instructed to quarantine all unused affected product in your inventory, return the affected product (contact Medtronic Customer Service at 800-848-9300 to initiate a product return) and complete & return the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic.com. \n\nFor questions contact your Medtronic Representative. If you require assistance in contacting your representative, please contact Medtronics National Answering Service at 800-633-8766.", "product_quantity": "5609 (663 US; 4946 OUS)", "distribution_pattern": "Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia, \nLebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.", "openfda": { "k_number": [ "K140181", "K014080", "K970463", "K843956", "K231982", "K781223", "K925626", "K923272", "K772284", "K803231", "K071494", "K241352", "K022115", "K844901", "K242503", "K926467", "K912078", "K810505", "K201642", "K980974", "K831705", "K810532", "K172984", "K231773", "K860673", "K760824", "K896978", "K961000", "K991452", "K910107", "K130209", "K071774", "K963518", "K203424", "K954850", "K000430", "K130359", "K112360", "K971877", "K925076", "K130333", "K162016", "K896671", "K894630", "K861641", "K812660", "K964043", "K926226", "K123314", "K191444", "K172071", "K102464", "K072091", "K031903", "K872133", "K082117", "K901253", "K903436", "K912655", "K862918", "K962667", "K101153", "K830639", "K080708", "K022450", "K030264", "K231414", "K143073", "K843955", "K020997", "K133261", "K882892", "K861177", "K895393", "K200109", "K780078", "K122827", "K883053", "K202206", "K810470", "K130493", "K180950", "K010478", "K141492", "K142784", "K941653", "K071572", "K031223", "K090511", "K901249", "K200683", "K960074", "K083021", "K823125", "K953835", "K890808", "K253838", "K013480", "K801240", "K831894", "K863249", "K912079", "K183490", "K061628", "K831895", "K872107", "K961734", "K830327", "K130280", "K023381", "K853080", "K821477", "K823456", "K883054", "K920889", "K240666", "K153295", "K931444", "K841476", "K912920", "K010443", "K833670", "K951247", "K043323", "K934292", "K790406", "K873923", "K130433", "K082403", "K897068", "K802970", "K891687", "K901250", "K100278", "K153213", "K090689", "K823343", "K090449", "K001021", "K964967", "K121536", "K250821", "K811004", "K153140", "K912082", "K941473", "K132829", "K051997", "K894826", "K000255", "K973760", "K933586", "K072362", "K151713", "K781842", "K893207", "K974812", "K894103", "K113626", "K962641", "K802328", "K974085", "K013038", "K802720", "K821216", "K925075", "K901624", "K130520", "K121229", "K211495", "K823273", "K892641", "K922933", "K790356", "K854045", "K223161", "K992910", "K172626", "K162896", "K993772", "K230640", "K874841", "K895632", "K231652", "K922799", "K802719", "K062381", "K222297", "K061031", "K851035", "K103191", "K190690", "K201916", "K121909", "K120185", "K772237", "K991737", "K853251", "K050447", "K990103", "K102109", "K090450", "K892664", "K040210", "K992559", "K020351", "K863476", "K033323", "K122844", "K833518", "K151389", "K894970", "K150267", "K202510", "K891230", "K093522", "K151791", "K833078", "K860539", "K961530", "K004001", "K932252", "K984271", "K092895", "K800555", "K240934", "K100645", "K140177", "K864235", "K911227", "K073380", "K183511", "K203111", "K180448", "K122254", "K150489", "K013915", "K191029", "K212341", "K953976", "K842908", "K833253", "K803003", "K813255", "K893704", "K863515", "K792039", "K850630", "K941225", "K880021", "K191246", "K822803", "K831122", "K140774" ], "registration_number": [ "3021599320", "9617601", "3019807891", "2184009", "3003752502", "1218444", "1928237", "3009507273", "1643817", "3030125051", "3011554160", "3008307705", "8010762", "9681834", "9680841", "3015136750", "3002807090", "3045892899", "2528981", "3002806603", "3014990448", "1124841", "1220648", "3010155661", "3013267343", "1319639", "1625519", "3010163695", "3005941719", "3016746283", "2011171", "2916596", "8010026", "3044156918" ], "fei_number": [ "3021599320", "3009649876", "3019807891", "3003752502", "1218444", "2828", "1000116158", "1928237", "3009507273", "1643817", "1000138054", "3030125051", "3006003617", "3011554160", "3008307705", "3015136750", "3045892899", "3002808327", "3005426550", "2528981", "3002806603", "3002534070", "3014990448", "1220648", "3010155661", "3002807111", "3013267343", "1625519", "3010163695", "3016746283", "2011171", "2916596", "3044156918", "3000204839" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }