{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183655", "product_res_number": "Z-0098-2021", "event_date_initiated": "2020-09-01", "event_date_created": "2020-10-13", "recall_status": "Terminated", "event_date_terminated": "2021-01-20", "res_event_number": "86410", "product_code": "FIP", "k_numbers": [ "K133829" ], "product_description": "AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies.\n\nAquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius Part Number: 24-1500-1\nAquaBplus B2 2000 / B1 2500 (Bplus DUO 2000) - 3 x 208V / 60Hz- Fresenius Part Number: 24-2000-0", "code_info": "9BDS1515 08D51544 OBDS1596 OBPS2864 9BDS1529 OBDS1545 OBPS2799 OBPS2884 9BPS2735 OBDS1551 OBPS2800 OBPS2903 9BPS2767 08D51590 OBPS2810", "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": "Fresenius Medical Care Technical Service\n800-553-1109", "reason_for_recall": "Incorrectly crimped connectors were installed on the main protective earth conductor on these machines. If the machine is moved or maintenance is performed, these crimp connections could become loose and may adversely affect the electrical safety of the\nproducts, potentially resulting in electrical shock to the Biomed Technician or clinic staff.", "root_cause_description": "Process control", "action": "Fresenius Medical Care issued letter dated 9/1/20 stating reason for recall, health risk and action to take: A Fresenius Medical Care Renal Therapies Group Water Systems Service Specialist will be contacting you to schedule an appointment to check the connection and replace if necessary.\nIn the meantime, we ask that you do not perform any repairs or maintenance on the machine and wait for your scheduled service date. For questions or concerns or if you need service prior to your scheduled service date, please contact Technical Support Services at 888-553-1109.", "product_quantity": "15 units", "distribution_pattern": "US distribution to DE, NC, OK, PA, and TX.", "openfda": { "k_number": [ "K042018", "K223656", "K001282", "K250514", "K841403", "K080703", "K083712", "K983126", "K142285", "K993806", "K021560", "K060942", "K161304", "K983239", "K931595", "K133829", "K030348", "K121022", "K992786", "K945136", "K915258", "K211035", "K974899", "K822385", "K123282", "K143617", "K090885", "K232953", "K153329", "K192398", "K994292", "K131622", "K993877", "K945066", "K842215", "K991916", "K041884", "K980182", "K981085", "K112331", "K944385", "K791086", "K182367", "K092481", "K042089", "K072158", "K082400", "K171099", "K110285", "K032004", "K102892", "K954928", "K952215", "K093608", "K001755", "K223479", "K161844", "K051620", "K250471", "K800305", "K133783", "K133149", "K945559", "K993520", "K030652", "K031832", "K983512", "K964539", "K920186", "K994279", "K033648", "K991495", "K954349", "K131904", "K022448", "K151637", "K993200", "K200670", "K011005", "K873487", "K041163", "K213507", "K894106", "K924695", "K030059", "K974127", "K021352", "K944493", "K061782", "K043344", "K231410", "K991519", "K110578", "K124059", "K003877", "K001811", "K981680", "K802474", "K042797", "K934848", "K000249", "K010592", "K811678", "K863720", "K944767", "K771763", "K071104", "K022747", "K252181", "K894300", "K003957", "K002045", "K013677", "K871242", "K111740", "K251851", "K014169" ], "registration_number": [ "3013764800", "8030665", "3010032903", "9611824", "3006426779", "3014279513", "9610270", "1833387", "3002879653", "1720309", "3010850471", "3010120135", "8010182", "3005695808", "1833920", "3004057358", "3014144799", "3038195011", "3010178296", "3016096143", "3010120148", "3005162618", "1651434", "3010867648", "3010866895", "3010863450", "1225714", "3007007791", "3017552925", "3006029151", "1055109", "9611369", "3013507157", "3003768032", "3003550196", "3038138522", "3015349756", "1530185", "3012119281", "3043014136", "3003337893", "3010355846", "3009959868", "1651723", "1833407", "9615942", "3017974963", "3019131", "3043543260", "3010041430", "3032828299", "3006755813", "3002807295", "3004188066", "3015335038", "3005578748", "9611823", "3010120326", "3004111573", "3035708507" ], "fei_number": [ "3013764800", "3010032903", "3012394756", "3006426779", "3014279513", "1833387", "3002879653", "1720309", "3010850471", "1000191953", "3010120135", "3005695808", "3003200197", "3004057358", "3014144799", "3038195011", "3006475063", "3002807005", "3002807744", "3016096143", "3010120148", "3010867648", "3010866895", "1000112932", "3002806960", "3010863450", "3007007791", "3006029151", "3017552925", "1000515504", "3013507157", "3003550196", "3038138522", "3015349756", "3013942511", "3012119281", "3043014136", "3003337893", "3010355846", "3009959868", "3017974963", "3002807035", "1527681", "3001451489", "3002807204", "3043543260", "3010041430", "3032828299", "1000115656", "1000518597", "3006755813", "3002807295", "3003043063", "3015335038", "3005578748", "3004188066", "3010120326", "3004111573", "3003110073", "3035708507" ], "device_name": "Subsystem, Water Purification", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5665", "device_class": "2" } } ] }