{ "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": "131553", "product_res_number": "Z-0870-2015", "event_date_initiated": "2014-11-05", "event_date_posted": "2014-12-24", "recall_status": "Terminated", "event_date_terminated": "2015-07-24", "res_event_number": "69795", "product_code": "DTZ", "k_numbers": [ "K100278" ], "product_description": "Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000\n\nFor cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.", "code_info": "k100278 Lot number 70100610", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Cardiovascular Us Sales, Llc", "address_1": "45 Barbour Pond Drive", "city": "Wayne", "state": "NJ", "postal_code": "07470", "additional_info_contact": "888-627-8383", "reason_for_recall": "Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.", "root_cause_description": "Process control", "action": "Maquet Inc. sent Urgent Product Recall - Removal Letters/Response Forms dated 11/5/2014.", "product_quantity": "28 units", "distribution_pattern": "Distributed in DC, MA, & MI.", "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" } } ] }