{ "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": "197048", "product_res_number": "Z-0734-2023", "event_date_initiated": "2022-07-27", "event_date_posted": "2022-12-20", "recall_status": "Open, Classified", "res_event_number": "91154", "product_code": "KDI", "k_numbers": [ "K173972" ], "product_description": "2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility\nModels:\n(1) 190713 2008T HEMODIALYSIS SYS., with CDX;\n(2) 190766 2008T HEMODIALYSIS SYSTEM W/BIBAG W/CDX ; \n(3) 191124 2008T HD SYS. CDX BLUESTAR; \n(4) 191126 2008T HD SYS. CDX W/BIBAG BLUESTAR", "code_info": "Software issue in SW versions 2.72 and earlier with CDX.\nUDI:\n(1) 00840861100897;\n(2) 00840861100910;\n(3) 00840861102082;\n(4) 00840861102099", "firm_fei_number": "3001451489", "recalling_firm": "Fresenius Medical Care Holdings, Inc.", "address_1": "920 Winter St Bld 950", "city": "Waltham", "state": "MA", "postal_code": "02451-1521", "additional_info_contact": "SAME\n781-6999580", "reason_for_recall": "(1)Software version 2.74 upgrade and (2)hardware related cause that affects only CDX Machines, has been identified as the UI-MICs Board is sensitive to Electromagnetic Interference (EMI) which will cause the false alarm \"Remove USB 2 Device\".", "root_cause_description": "Process design", "action": "Fresenius issued Updated Urgent Medical Device Correction REV B Customer Notification letter (Field Action Number: FA-2020-09-W _REV B) to consignees that have CDX equipped machines on 07-27-2022 via USPS First Class Mail. Letter states reason for recall, health risk and action to take:\nFirst, a software issue in SW versions 2.72 and earlier. All machines should be updated to current software (SW version 2.74), pursuant to the July 20, 2021, letter.\n\nSecond, hardware issue that affects only CDX machines.\nTo reduce the chance of EMI causing a false Remove USB Device 2 alarm from occurring we suggest the following:\n\" Insert a USB device in USB Port 2 that will continually draw current. For example, a blank USB memory stick or a USB powered card reader.\no NOTE: DO NOT use passive USB devices in USB Port 2 that go into a suspended state\ndrawing minimal/low current which can trip the sensing circuit. An example would be a\nUSB corded optical mouse. \nComplete/Return the response form enclosed.", "product_quantity": "2008T with CDX= 70,552 2008T Bluestar with CDX= 25,205", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K131381", "K834589", "K945542", "K926373", "K051187", "K041005", "K871108", "K121341", "K883407", "K122051", "K812575", "K160881", "K970591", "K133547", "K223248", "K050727", "K832645", "K030974", "K963440", "K790827", "K962427", "K093120", "K012510", "K103832", "K060008", "K945747", "K253518", "K182940", "K933883", "K011221", "K031378", "K150708", "K023664", "K112314", "K220721", "K122347", "K240394", "K914363", "K982926", "K113427", "K924437", "K061837", "K231406", "K153449", "K951311", "K994267", "K242053", "K070320", "K001156", "K992275", "K042938", "K952982", "K083158", "K083778", "K870724", "K910236", "K071518", "K843014", "K091978", "K213639", "K233335", "K955592", "K160558", "K030592", "K863961", "K201809", "K243920", 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"K061519", "K980386", "K830595", "K974584", "K040489", "K050603", "K926568", "K830648", "K895405", "K162488", "K013550", "K954987", "K260533", "K013733", "K192707", "K070512", "K212216", "K823288", "K893742", "K970446", "K013418", "K152938", "K083460", "K023874", "K963203", "K232803", "K992564", "K081313", "K162248", "K060195", "K190793", "K090682", "K931720", "K800536", "K170574", "K160444", "K942681", "K243237", "K983085", "K823881", "K021615", "K153344", "K840449", "K113023", "K050952", "K820243", "K080964", "K864169", "K024124", "K080519", "K982413", "K950522", "K003498", "K952978", "K961465", "K872456", "K020858", "K133299", "K120017", "K890315", "K233557", "K072093", "K900918", "K173972", "K830647", "K170790", "K002210", "K183158", "K991520", "K993064", "K900018", "K014152", "K003023", "K131908", "K981681", "K926379", "K123288", "K945595", "K861776", "K013562", "K063183", "K895759", "K801731", "K053539", "K243264", "K855251", "K210661", "K002277", "K850979", "K243505", "K945597", "K252377", "K823338", "K970253", "K873887", "K131935", "K902837", "K010131", "K071298", "K250508", "K131050", "K883195", "K253412", "K051520", "K040696", "K841152", "K011537", "K103564", "K203062", "K884365", "K811944", "K123395", "K992566", "K850866", "K252459", "K980859", "K953996", "K082414", "K011269", "K971180", "K813591", "K030099", "K072232", "K913950", "K960474", "K952983", "K801480", "K901286", "K232171", "K050609", "K062090", "K832547", "K801303", "K131516", "K030975", "K994198", "K923312", "K132602", "K831784", "K003425", "K955487", "K001422", "K883307", "K992573", "K923139", "K140866", "K830284", "K030050", "K811830", "K840680", "K143482", "K220281", "K211370", "K973322", "K854011", "K000028", "K143313", "K041726", "K903641", "K945621", "K863823", "K192928", "K021732", "K001283", "K110823", "K140191", "K261267", "K830487", "K171671", "K840543", "K853333", "K070643", "K232776", "K884353", "K034064", "K992563", "K854309", "K852251", "K914020", "K860938", "K062922", "K190910", "K982760", "K872767", "K163530", "K974652", "K780527" ], "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2", "registration_number": [ "3001744144", "3013536188", "2032098", "9615942", "9610825", "3043226252", "3013557562", "3015335038", "1000286794", "3009128476", "3016678045", "3012102437", "3003504604", "1056186", "3040314808", "3008102042", "3035708507", "3000247873", "3002879653", "3002807408", "8030665", "1713747", "9681465", "3013188547", "3011554160", "3005162618", "3012149633", "9680841", "9680579", "3004176176", "3038195011", "3015349756", "3008229990", "9611823", "9616240", "3005695808", "3004111573", "3005941719", "9611369", "3012494290", "3032828299", "3014272786", "3038138522", "3003464075", "3020689844", "3003661577", "3003589956", "9611824", "8041145", "1047843", "8010182", "3043014136", "3033903155", "9612052", 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