{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "178112", "product_res_number": "Z-0677-2020", "event_date_initiated": "2019-11-13", "event_date_created": "2019-12-12", "recall_status": "Open, Classified", "res_event_number": "84352", "product_code": "DTZ", "k_numbers": [ "K100278" ], "product_description": "Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile\nREF: BEQ-HMOD 30000", "code_info": "Lot codes: 70114704, 70120471, 70123847, 70123854, 70124528, 70124693, 70127336, 70130216, 70123853, 70129395, 7011472 05, 70121444, 70123849, 70124474, 70124529, 70124694, 70127498, 70131871, 70124527, 70113694, 70120282, 70121445, 70123850, 70124525, 70124689, 70124695, 70127499, 70120470, 70124692, 70120283, 70121668, 70123852, 70124526, 70124691, 70124696, 70128623, 70122004, 70127335  UDI Code: 04037691670164", "firm_fei_number": "3012092534", "recalling_firm": "GETINGE US SALES LLC", "address_1": "45 BARBOUR POND DR", "city": "WAYNE", "state": "NJ", "postal_code": "07470", "reason_for_recall": "Sterile barrier system may be compromised", "root_cause_description": "Package design/selection", "action": "Getinge issued Urgent Medical Device Removal Letter on 11/13/19 via Fedex 2 Day delivery with Signature Proof of Delivery (SPOD) required. Letter states\" Identification of Issue, Health Risk and action to take: examine your inventory immediately to determine if you have any of the lot/batch numbers listed in this recall notice. If so, please remove the affected products from areas of use and follow the instructions to return of the product to Getinge. Unused and unexpired affected product that is returned to Getinge is eligible for full credit.\nAffected product should be returned to Getinge.\n\nCall Maquet/Getinge Customer Support at +1(888) 627- 8383 (press option 2, then option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone), to request a return material authorization (RMA) and shipping instructions to return any affected product. \nComplete the response form and return fax or email the completed Customer Response Form to 1-800-574-5051 OR QuadroxiDPediatricFA.US@getinge.com", "product_quantity": "3633 US", "distribution_pattern": "Nationwide\nCanada", "openfda": { "k_number": [ "K013038", "K130280", "K941225", "K843955", "K112360", "K231414", "K844901", "K151791", "K202206", "K231773", "K121536", "K000430", "K141492", "K896671", "K090449", "K980974", "K072362", "K031223", "K970463", "K931444", "K922933", "K893704", "K090689", "K151389", "K202510", "K792039", "K180950", "K941653", "K801240", "K130333", "K953976", "K831894", "K910107", "K912079", "K974812", "K883054", "K130520", "K922799", "K993772", "K911227", "K912078", "K894630", "K004001", "K191029", "K010443", "K874841", "K760824", "K022450", "K122827", "K954850", "K854045", "K850630", "K222297", "K183511", "K964043", "K800555", "K925075", "K912655", "K083021", "K180448", "K101153", "K802970", "K896978", "K231652", "K893207", "K162016", "K860673", "K873923", "K190690", "K153213", "K880021", "K923272", "K100278", "K962667", "K901253", "K040210", "K830327", "K841476", "K790356", "K813255", "K230640", "K833253", "K901250", "K932252", "K963518", "K143073", "K140181", "K811004", "K802720", "K823343", "K831705", "K861177", "K071572", "K853251", "K823273", "K023381", "K082403", "K894970", "K142784", "K014080", "K973760", "K203111", "K253838", "K821216", "K172071", "K926226", "K121229", "K920889", "K062381", "K162896", "K810505", "K071494", "K061628", "K803003", "K934292", "K810470", "K961530", "K123314", "K812660", "K872133", "K010478", "K951247", "K961000", "K991452", "K240666", "K033323", "K790406", "K895393", "K781842", "K895632", "K043323", "K200109", "K073380", "K882892", "K894826", "K130359", "K831895", "K241352", "K201916", "K823125", "K133261", "K140177", "K122844", "K962641", "K925626", "K891230", "K150267", "K031903", "K121909", "K892664", "K113626", "K022115", "K897068", "K772284", "K050447", "K090511", "K071774", "K223161", "K823456", "K092895", "K851035", "K863476", "K172984", "K810532", "K903436", "K090450", "K901249", "K203424", "K242503", "K211495", "K250821", "K153295", "K862918", "K861641", "K201642", "K020997", "K853080", "K150489", "K864235", "K212341", "K082117", "K780078", "K001021", "K912082", "K991737", "K901624", "K130209", "K093522", "K842908", "K122254", "K191246", "K153140", "K971877", "K803231", "K912920", "K000255", "K240934", "K102464", "K974085", "K822803", "K231982", "K843956", "K883053", "K933586", "K030264", "K151713", "K802328", "K120185", "K172626", "K140774", "K960074", "K964967", "K833078", "K890808", "K830639", "K061031", "K020351", "K191444", "K781223", "K051997", "K013915", "K860539", "K772237", "K992559", "K080708", "K984271", "K013480", "K891687", "K183490", "K132829", "K892641", "K802719", "K130493", "K961734", "K925076", "K992910", "K863515", "K200683", "K953835", "K926467", "K831122", "K072091", "K821477", "K990103", "K130433", "K894103", "K102109", "K833518", "K103191", "K833670", "K100645", "K863249", "K941473", "K872107" ], "registration_number": [ "2916596", "1643817", "3008307705", "9617601", "1625519", "3010155661", "3021599320", "3044156918", "8010762", "1319639", "3011554160", "3009507273", "3003752502", "3014990448", "3015136750", "1220648", "1124841", "1218444", "9680841", "8010026", "3013267343", "3045892899", "3019807891", "3010163695", "2184009", "2528981", "3030125051", "1928237", "3005941719", "9681834", "3016746283", "3002806603", "2011171", "3002807090" ], "fei_number": [ "2916596", "3000204839", "1643817", "3008307705", "3006003617", "3009649876", "1625519", "3010155661", "3021599320", "3044156918", "2828", "1000116158", "3011554160", "3009507273", "3003752502", "3002808327", "3014990448", "3015136750", "1000138054", "1220648", "1218444", "3005426550", "3013267343", "3045892899", "3019807891", "3010163695", "2528981", "3030125051", "1928237", "3002807111", "3016746283", "3002806603", "3002534070", "2011171" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }