{ "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": "106185", "product_res_number": "Z-0689-2012", "event_date_initiated": "2011-09-22", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-09-18", "res_event_number": "60673", "product_code": "DTZ", "k_numbers": [ "K100278" ], "product_description": "MAQUET QUADROX iD PEDIATRIC -OXYGENATOR:\nBEQ-HMOD 3000; Made In Germany\n\nThe diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours.", "code_info": "510(k) numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD 30000 70064002-28 units 70064004-140 units", "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": "Ms. Karen LeFevere\n973-709-7652", "reason_for_recall": "There are reports of leakage in the Leuer connector of the blood outflow connector of the Quadrox-iD pediatric oygenator.", "root_cause_description": "Device Design", "action": "The firm, Maquet Getinge Group, sent an \"PRODUCT RECALL URGENT-MEDICAL DEVICE REMOVAL ACTION\" letter dated September 22, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed tocheck their remaining inventory; remove product immediately to prevent use; remove the boxes or individually pouched oxygenators in a secure area of their facility and notify their MAQUET representative (a representative will physically remove the recalled product and replenish the removed units); and complete and return the enclosed Product Removal Disposition Form via fax to: (973)-807-9210 or email: whitney.torning@maquet.com.\n\nShould you have any questions or concerns, please do not hesitate to contact MAQUET Customer Service at 800-777-4222.", "product_quantity": "168 units", "distribution_pattern": "Nationwide distribution: AL, CA, DE, DC, FL, GA, HI, IL, IN, LA, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, and TX.", "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" } } ] }