{ "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": 2 } }, "results": [ { "cfres_id": "180486", "product_res_number": "Z-1748-2020", "event_date_initiated": "2020-03-12", "event_date_created": "2020-04-20", "recall_status": "Open, Classified", "res_event_number": "85310", "product_code": "KDI", "k_numbers": [ "K173972" ], "product_description": "Fresenius 2008T Hemodialysis Machine:\nPart Number Description\n190573 2008T HEMODIAL YSIS SYS. OLC/DIASAFE PLUS;\n190713 2008T HEMODIAL YSIS SYS., with CDX;\n190766 2008T HEMODIAL YSIS SYSTEM W/BIBAG;\n190858 2008T HEMODIAL YSIS SYSTEM WITHOUT CDX;\n190895 2008T GEN 2 BIBAG WITHOUT CDX;\n190908 2008T HD System With CDX, CAN", "code_info": "All serial numbers", "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": "A \"Remove USB Device 2\" false alarm may be displayed when no USB device or a non-powered USB device is connected to the USB port on the rear of the machine", "root_cause_description": "Software design", "action": "Fresenius Medical Care issued via First Class Mail on 03-12-2020 Important Medical Device Correction Customer Notification explaining the issue, health risk and action to take: To clear the alarm, tum the machine power off for 30 to 45 seconds and turn back on. If the alarm has not been cleared, repeat the power off cycle again. If still not cleared, perform a manual blood return and remove the patient from the machine. Remove the machine from service and contact a qualified service technician. This alarm may reoccur even after a power cycle has been performed. true alarm will only occur when an externally powered USB device is connected. Refer to the Operators Manual Troubleshooting section for instructions. A Reply Form included for confirmation the consignee read and understands the notice sent to them and ask for number of machines corrected.\n\nA software solution is being created that addresses this situation. Once the software upgrade is available, an additional notification will be sent with instructions on how to order the upgrade at no charge. \n\nIf you experience this issue or have additional questions, please contact Fresenius Medical Care Technical Services at 800-227-2572", "product_quantity": "101,463", "distribution_pattern": "Nationwide\nForeign: Canada, Curaca, Guam", "openfda": { "k_number": [ "K840543", "K210575", "K992894", "K162248", "K000724", "K173972", "K800536", "K130039", "K813591", "K921134", "K170574", "K920757", "K252459", "K854586", "K232803", "K031378", "K171331", "K853333", "K100334", "K994198", "K970591", "K926373", "K820243", "K945597", "K780527", "K980859", "K032356", "K923139", "K823338", "K113427", "K850866", "K190793", "K123262", "K131908", "K830647", "K123395", "K011221", "K080650", "K103564", "K190910", "K061837", "K041726", "K023664", "K233798", "K231534", "K123288", "K890315", "K974652", "K854309", "K823589", "K010131", "K911603", "K131050", "K841152", "K030974", "K042938", "K963440", "K051520", "K103832", "K883407", "K082414", "K884365", "K973516", "K162488", "K992275", "K223248", "K001422", "K945747", "K062922", "K200741", "K003498", "K954987", "K831784", "K070222", "K153344", "K923727", "K030099", "K952978", "K844663", "K041005", "K253518", "K884353", "K243874", "K010805", "K923312", "K093069", "K231406", "K020858", "K981681", "K946279", "K003023", "K113023", "K121497", "K071854", "K050952", "K210661", "K140191", "K902837", "K050525", "K951344", "K013418", "K864169", "K970739", "K091978", "K120017", "K212216", "K260533", "K970253", "K152938", "K023874", "K192707", "K083778", "K864587", "K150880", "K040696", "K011269", "K201809", "K243505", "K112314", "K840680", "K910236", "K014152", "K160558", "K222952", "K945625", "K980386", "K051187", "K070643", "K962427", "K914363", "K132602", "K131516", "K952342", "K081313", "K873887", "K832547", "K926379", "K170469", "K242155", "K960474", "K050603", "K192756", "K203062", "K013733", "K992573", "K071518", "K843014", "K053539", "K834589", "K893742", "K872456", "K071298", "K990643", "K901286", "K222067", "K955592", "K070512", "K002277", "K070320", "K232776", "K193482", "K243920", "K951311", "K790827", "K011537", "K171671", "K213639", "K211370", "K072093", "K992566", "K062079", "K961465", "K060195", "K991520", "K962707", "K933818", "K050727", "K002210", "K160444", "K193005", "K895759", "K982760", "K090682", "K013562", "K193542", "K121341", "K982413", "K110823", "K840449", "K870724", "K830595", "K093120", "K021615", "K812575", "K945621", "K143482", "K945620", "K140526", "K152367", "K030975", "K030050", "K992563", "K261267", "K220281", "K242053", "K953996", "K003425", "K832645", "K131381", "K143313", "K122051", "K060008", "K853510", "K892262", "K001250", "K080964", "K872767", "K243237", "K183158", "K253412", "K955487", "K000028", "K133547", "K982414", "K080519", "K153449", "K220721", "K942681", "K830284", "K781464", "K072232", "K250508", "K861106", "K980656", "K852251", "K971180", "K913950", "K982926", "K182940", "K830596", "K120505", "K061519", "K900018", "K883307", "K811830", "K801479", "K914020", "K830487", "K993064", "K801303", "K032431", "K964922", "K811944", "K041424", "K233335", "K030592", "K854011", "K083158", "K133299", "K063183", "K170790", "K071263", "K832659", "K101715", "K955384", "K801480", "K801731", "K193670", "K013550", "K040255", "K952982", "K231125", "K823881", "K021732", "K243264", "K150708", "K192928", "K931720", "K911094", "K160881", "K884326", "K863823", "K163530", "K952983", "K970446", "K963203", "K973322", "K945596", "K050609", "K111639", "K010985", "K012510", "K093964", "K992564", "K082515", "K830648", "K230632", "K983085", "K841585", "K121409", "K001156", "K024124", "K900918", "K933883", "K002512", "K950522", "K034064", "K232171", "K883195", "K023224", "K844790", "K062090", "K903641", "K083460", "K001283", "K122343", "K122347", "K926568", "K852885", "K945595", "K232467", "K863961", "K945542", "K140866", "K040489", "K861776", "K043244", "K823288", "K994267", "K093902", "K252377", "K850979", "K023509", "K860938", "K233557", "K895405", "K093379", "K131935", "K871108", "K240394", "K855251", "K982134", "K924437", "K974584", "K010667" ], "registration_number": [ "1056186", "9680579", "3015349756", "3013557562", "3002807408", "3008307705", "3012494290", "3006755813", "3032828299", "3004201412", "3038195011", "9610987", "1225714", "3015136750", "3003589956", "9680841", "3014300273", "3010383847", "3005941719", "3005695808", "9610270", "3014479313", "3009128476", "3033903155", "8031561", "3005578748", "2032098", "3043014136", "3016250252", "9615942", "3008102042", "3035708507", "3008229990", "8041145", "3038138522", "2183744", "9612052", "3014279513", "9616240", "3027592507", "3004176176", "3016096143", "3007137787", "3014579161", "3017552925", "3021632375", "3015335038", "1000286794", "1047843", "3000247873", "1713747", "3010355846", "3010377171", "9611823", "3040314808", "3020689844", "9611369", "3013536188", "3004530184", "3003464075", "8030665", "3001744144", "3003337893", "9610825", "3014272786", "3010291427", "3012102437", "8030639", "3012149633", "9611824", "9681465", "3013188547", "3043226252", "3004111573", "3011554160", "9616074", "3003504604", "3005162618", "1649518", "3002879653", "3016678045", "1721676", "3031565407", "1000312731", "3006174295", "8010182", "3015472042", "3003661577", "3013764800" ], "fei_number": [ "3015349756", "3013557562", "3002807408", "3002807005", "3008307705", "3002806443", "3002807744", "1000203464", "3012494290", "3002807204", "3006755813", "3032828299", "3004201412", "3038195011", "3003589956", "3015136750", "3014300273", "3005426550", "3012394756", "3010383847", "3002807111", "3002807721", "3002974635", "3005695808", "3014479313", "3009128476", "3033903155", "3005578748", "1527681", "3043014136", "3016250252", "3035708507", "3008229990", "3038138522", "2183744", "1000132332", "3014279513", "3027592507", "3002807113", "3004176176", "3016096143", "3007137787", "3014579161", "3017552925", "6898", "3021632375", "3015335038", "1000286794", "1047843", "3000247873", "3002807196", "1713747", "3002807710", "3010355846", "3010377171", "3040314808", "3020689844", "3013536188", "3004530184", "3003464075", "3002806469", "3002924544", "3001744144", "3003337893", "3001236277", "3002806960", "3014272786", "3010291427", "3001451489", "3012102437", "3002807035", "3012149633", "3013188547", "1000191953", "3043226252", "3004111573", "3011554160", "3003058448", "3003504604", "3002879653", "3016678045", "1721676", "3031565407", "1000312731", "3006174295", "3015472042", "3003661577", "3013764800", "3002654698" ], "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2" } } ] }