{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "195612", "product_res_number": "Z-1764-2022", "event_date_initiated": "2022-07-22", "event_date_created": "2022-09-19", "recall_status": "Open, Classified", "res_event_number": "90740", "product_code": "DTZ", "k_numbers": [ "K112360" ], "product_description": "BEQ-HLS 7050 USA; \nHLS Set Advanced 7.0 \nPart No. 70105.2794. \nA preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.", "code_info": "UDI-DI: 04037691741543\n\nLots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Medical Systems USA", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "Allison Jean Kaplan\n973-709-7000", "reason_for_recall": "The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).", "root_cause_description": "Package design/selection", "action": "On July 15, 2022, the firm notified affected customers via Urgent Medical Device Removal Expansion letter. The letter informed customers of the inclusion of additional product codes and lots into the earlier recall initiated on November 6, 2020.\n\nCustomers were instructed to examine their inventory and identify any affected product on hand. Affected product in use may be continued to be used according to normal practices.\n\nUnused and unexpired affected product should be immediately returned to Getinge for credit.\n\nPlease contact Getinge Customer\nService at (888) 9GETUSA / (888) 943-8872 (press option 2) between the hours of\n8:00 a.m. and 6:00 p.m. Eastern Standard Time to request a return authorization\n(RMA) and shipping instructions to return any affected product.\n\nAt this time, the recalling firm has already implemented the more durable Tyvek accessory packaging in all product manufactured September 2021 and later.", "product_quantity": "206 US; 48,960 Worldwide", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries Canada and Australia.", "openfda": { "k_number": [ "K861177", "K962667", "K851035", "K000430", "K121536", "K830639", "K140774", "K941653", "K150267", "K911227", "K974085", "K223161", "K162896", "K061031", "K100645", "K201916", "K022115", "K893704", "K071494", "K072362", "K964967", "K850630", "K090449", "K863476", "K101153", "K122844", "K250821", "K863249", "K896671", "K130359", "K812660", "K183511", "K231982", "K803003", "K231773", "K853251", "K962641", "K810470", "K860673", "K841476", "K072091", "K020997", "K833670", "K833253", "K781223", "K172626", "K142784", "K844901", "K230640", "K122827", "K823343", "K920889", "K864235", "K183490", "K071572", "K031223", "K974812", "K083021", "K772284", "K932252", "K991737", "K941473", "K200109", "K883054", "K941225", "K092895", "K970463", "K897068", "K883053", "K130280", "K951247", "K031903", "K821216", "K191029", "K010443", "K082117", "K810532", "K831895", "K172984", "K910107", "K113626", "K925075", "K971877", "K132829", "K212341", "K202510", "K191444", "K203424", "K901249", "K180950", "K231652", "K050447", "K853080", "K831894", "K760824", "K130209", "K894103", "K854045", "K863515", "K151389", "K090450", "K830327", "K102464", "K781842", "K023381", "K071774", "K893207", "K802720", "K912082", "K112360", "K780078", "K873923", "K801240", "K991452", "K901250", "K933586", "K240934", "K843955", "K802970", "K961000", "K121909", "K980974", "K872107", "K901624", "K191246", "K800555", "K843956", "K073380", "K242503", "K954850", "K960074", "K162016", "K222297", "K822803", "K013915", "K894826", "K903436", "K122254", "K922933", "K862918", "K861641", "K014080", "K912078", "K211495", "K823273", "K013480", "K201642", "K153213", "K130493", "K874841", "K993772", "K082403", "K912079", "K831705", "K051997", "K172071", "K803231", "K813255", "K130333", "K953976", "K153140", "K964043", "K831122", "K926226", "K912655", "K203111", "K890808", "K923272", "K120185", "K891230", "K802719", "K931444", "K010478", "K953835", "K984271", "K833078", "K090689", "K121229", "K811004", "K895632", "K925626", "K062381", "K080708", "K100278", "K872133", "K253838", "K880021", "K922799", "K792039", "K821477", "K022450", "K140177", "K882892", "K926467", "K030264", "K180448", "K103191", "K860539", "K020351", "K093522", "K833518", "K963518", "K790356", "K231414", "K892641", "K033323", "K000255", "K973760", "K143073", "K061628", "K240666", "K130433", "K190690", "K990103", "K202206", "K961734", "K823125", "K925076", "K090511", "K901253", "K040210", "K894630", "K790406", "K102109", "K802328", "K772237", "K140181", "K892664", "K001021", "K004001", "K123314", "K013038", "K151713", "K992559", "K896978", "K934292", "K895393", "K130520", "K133261", "K150489", "K153295", "K241352", "K151791", "K842908", "K992910", "K961530", "K200683", "K141492", "K912920", "K891687", "K810505", "K043323", "K894970", "K823456" ], "registration_number": [ "3021599320", "1319639", "9617601", "3015136750", "2011171", "1625519", "3044156918", "2184009", "3030125051", "3019807891", "1218444", "9681834", "8010762", "3009507273", "3011554160", "2916596", "3014990448", "3016746283", "9680841", "1928237", "1643817", "3010155661", "3002807090", "1220648", "3005941719", "3013267343", "3008307705", "1124841", "8010026", "2528981", "3003752502", "3002806603", "3045892899", "3010163695" ], "fei_number": [ "3021599320", "1000138054", "3015136750", "2011171", "1625519", "3044156918", "3002534070", "3002807111", "3030125051", "3019807891", "1218444", "3006003617", "1000116158", "3000204839", "3009507273", "2828", "3011554160", "2916596", "3014990448", "3016746283", "1928237", "1643817", "3009649876", "3002808327", "3010155661", "1220648", "3013267343", "3008307705", "2528981", "3003752502", "3002806603", "3005426550", "3045892899", "3010163695" ], "device_name": "Oxygenator, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4350", "device_class": "2" } } ] }