{ "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": "168746", "product_res_number": "Z-0504-2019", "event_date_initiated": "2018-10-17", "event_date_created": "2018-11-27", "recall_status": "Terminated", "event_date_terminated": "2020-08-26", "res_event_number": "81445", "product_code": "KPO", "k_numbers": [ "K053286" ], "product_description": "NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis\n\n NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.", "code_info": "Lot Numbers: F1708230, F1708231, F1708234, F1708235, F1708237, F1708245, F1708246, F1708247, F1708250, F1708251, F1708253, F1708254, F1708256, F1709260, F1709261, F1709267, F1710327, F1710328, F1711343, F1711344, F1711345, Q1711844, Q1711853, Q1711854, Q1711855, Q1712025, Q1712091, Q1712092, Q1712137, Q1801146, Q1801147, Q1801148, Q1801149, Q1801151, Q1801202, Q1801221, Q1801225, Q1801226, Q1801335, Q1801336, Q1801337, Q1801338, Q1801339, Q1801340, Q1802507, Q1802508, Q1802509, Q1802510, Q1802511, Q1802512, Q1803685, Q1803686, Q1803687, Q1803690, Q1803750, Q1803754, Q1803755, Q1803774, Q1803775, Q1803776, Q1803847, Q1803848, Q1803849, Q1804888", "firm_fei_number": "3003464075", "recalling_firm": "NxStage Medical, Inc.", "address_1": "350 Merrimack St", "city": "Lawrence", "state": "MA", "postal_code": "01843-1748", "additional_info_contact": "SAME\n978-687-4700", "reason_for_recall": "PureFlow B Solution smaller chamber of the two chamber\nbag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin", "root_cause_description": "Packaging process control", "action": "NxStage initiated a recall on October 17, 2018 via \" URGENT MEDICAL DEVICE REMOVAL\" Recall Notice to its customers. The notice provided reason for recall, health risk, action to be taken. The customers were instructed to do the following: \n1 Check all boxes in your Pureflow B solution inventory, separate them from your other inventory and do not use them.\n2. Follow the instructions on the attached reply form or click on the following link to respond electronically, https://www.nxstage.com/rfprecalloct2018, to acknowledge your receipt of this notice.\n3. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent,\n\nIf you have any questions or comments, please feel free to contact NxStage Customer Service 1-866- NXST AGE (1-866-697-8243).", "product_quantity": "114777", "distribution_pattern": "US Nationwide Distribution.", "openfda": { "k_number": [ "K120333", "K980659", "K864265", "K130511", "K792513", "K993212", "K020231", "K180679", "K864942", "K022521", "K851431", "K191474", "K990507", "K910319", "K023985", "K982813", "K901472", "K202508", "K131611", "K120005", "K780353", "K041683", "K813586", "K792213", "K891159", "K150966", "K011368", "K811706", "K884725", "K030497", "K981043", "K895199", "K010760", "K012328", "K971053", "K212052", "K954527", "K982378", "K071387", "K901471", "K052253", "K854206", "K891921", "K983618", "K022500", "K883068", "K192017", "K834538", "K053286", "K162716", "K072760", "K022913", "K800624", "K070177", "K233950", "K223431", "K050827", "K880102", "K062399", "K020230", "K810527", "K013655", "K922990", "K212620", "K034066", "K013448", "K781967", "K102194", "K233159", "K861156", "K072908", "K821304", "K001059", "K052393", "K131202", "K090002", "K832866", "K221652", "K904946", "K192209", "K872857", "K903835", "K810280", "K191093", "K910270", "K240920", "K162887", "K252180", "K823779", "K171750", "K905021", "K863631", "K852955", "K810925", "K013724", "K911459", "K973253", "K042045", "K160847", "K000792", "K820150", "K893991", "K896111", "K193155", "K233213", "K033386", "K171015", "K243786", "K041428", "K990010", "K922005", "K843866", "K012547", "K922088", "K813388", "K901473", "K870979", "K865078", "K941958", "K253462", "K823103", "K940601", "K981003" ], "registration_number": [ "1835498", "2183415", "3003464075", "1225714", "3003591774", "2029275", "8030639", "3007137482", "1954315", "3005162618", "3012364195", "3010242164", "3005578748", "3027241826", "9610270", "1528807", "3004176176", "3038195011", "9616277", "9611823", "3016096143", "3013546115", "3043014136", "1056186", "1651896", "3035708507", "3027592507", "3013764800", "3032828299", "1652176", "2431908", "3019131", "9610725", "3003768032" ], "fei_number": [ "2183415", "6898", "3003464075", "3003591774", "3012364195", "1000306431", "3010242164", "3005578748", "3027241826", "3002970979", "405", "3013942511", "3001451489", "3003310249", "3004176176", "3038195011", "3003244997", "3012394756", "3016096143", "3013546115", "3043014136", "3002807005", "1000132332", "3035708507", "3006475063", "3001236991", "3027592507", "1000142899", "3013764800", "3003463852", "3032828299", "2431908", "1527681", "3007137482" ], "device_name": "Dialysate Concentrate For Hemodialysis (Liquid Or Powder)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5820", "device_class": "2" } } ] }