{ "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": "130099", "product_res_number": "Z-0080-2015", "event_date_initiated": "2013-10-17", "event_date_posted": "2014-10-17", "recall_status": "Terminated", "event_date_terminated": "2016-01-04", "res_event_number": "69253", "product_code": "KDJ", "k_numbers": [ "K791899" ], "product_description": "15 L Cycler Drainage Bag\n\nProduct Usage:\nFor use with Baxter Cycler Tubing sets as a peritoneal dialysis accessory.", "code_info": "Lot numbers: H12K20044, H12K20085, H12K21026, H13B04052, H13B04086, H13B05042, H13B05067, H13B06073, H13B07063, H13B13087, H13B14069, H13B14085, H13B15066, H13B18029, H13B18084, H13B20108, H13B22013, H13B22062, H13B23060, H13B24043, H13B25032, H13B25107, H13C06030, H13C06055, H13C07053, H13C07087, H13C08051, H13C09026, H13C09034, H13C09075, H13C11089, H13C12046, H13C12061, H13C13069, H13C19124, H13C20031, H13C20106, H13C21054, H13C22029, H13C25048, H13C25071, H13C26038, H13C26137, H13D02086, H13D03068, H13D04033, H13D04108, H13D10089, H13D10097, H13D11087, H13D12051, H13D12101, H13D13034, H13D13067, H13D15070, H13D15112, H13D16078, H13D16110, H13D19056, H13D19098, H13D20013, H13D20062, H13D21029, H13D22043, H13D22084, H13D23025, H13D23041, H13D24064, H13D25020, H13D25095, H13E01036, H13E01077, H13E02026, H13E02091, H13E03016, H13E07116, H13E08023, H13E08049, H13E09070, H13E10011, H13E10029, H13E13015, H13E13031, H13E14088, H13E14104, H13E15036, H13E21083, H13E22073, H13E23022, H13E23055, H13E24012, H13E24061, H13E28047, H13E28088, H13E29029, H13E30035, H13E30092, H13F04095, H13F04129, H13F05084, H13F06025, H13F06060, H13F07056, H13F11033, H13F12049, H13F12072, H13F12122, H13F13039, H13F13070, H13F14094, H13F18087, H13F19036, H13F20018, H13F20091, H13F21016, H13F21073, H13F22014, H13F22063, H13F25041, H13F25090, H13F26031, H13F26072, H13F27013, H13F27054, H13F28029, H13G09084, H13G10025, H13G10124, H13G11064, H13G12039, H13G12088, H13G16105, H13G17046, H13G18010, H13G18101, H13G19067, H13G19109, H13G23069, H13G24018, H13G24075, H13G25015, H13G25023, H13G26013, H13G26070, H13G31054, H13G31104, H13H01055, H13H02012, H13H02095, H13H05049, H13H06054, H13H06120, H13H07045, H13H13019, H13H13035, H13H13092, H13H14025, H13H14090, H13H15048, H13H15105, H13H20030, H13H20063, H13H21046, H13H21079, H13H22028, H13H22077, H13H23042", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corp", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n800-422-9837", "reason_for_recall": "The large tube clamp used to close the drain tube on the 15 L Cycler Drainage Bag may not fully close the drain tube and may result in leakage.", "root_cause_description": "Component change control", "action": "Baxter sent an Urgent Product Recall letter dated May 30, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. The recalling firm is instructing their customers to remove all affected products from their facility and quarantine the product subject to the recall. Customers are instructed to return the affected product to Baxter and receive a credit or replacement. For questions contact the Center for One Baxter at 1-800-422-9837.", "product_quantity": "3,085,080", "distribution_pattern": "Worldwide Distribution - US Nationwide (including Puerto Rico) and countries of, Canada, Australia, New Zealand, Thailand, Malaysia, Singapore, Korea, Japan, Philippines, Columbia, Ecuador, Austria, Bahran, Belgium, Bosnia & Herzegovina, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Hungary, Ireland, Isreal, Italy, Jordan, Kazakhstan, Latvia, Luxembourg, Malta, Norway, Oman, Poland, Portugal, Qatar, Russia, Saudi Arabia, Slovakia, South Africa, Spain (including Canary Islands), Sweden, Switzerland, The Netherlands, Turkey and United Arad Emirates.", "openfda": { "k_number": [ "K895991", "K860230", "K895990", "K892870", "K173363", "K883393", "K900106", "K871583", "K896599", "K772236", "K870145", "K800993", "K921818", "K900242", "K031676", "K894783", "K781755", "K041792", "K912208", "K812772", "K811863", "K896600", "K173593", "K945567", "K780957", "K801220", "K900006", "K810600", "K892871", "K772136", "K882455", "K851208", "K813069", "K925403", "K904806", "K812771", "K042900", "K811294", "K900295", "K972579", "K882498", "K900004", "K920586", "K791512", "K895792", "K780082", "K895992", "K853550", "K893712", "K820546", "K900005", "K022412", "K920029", "K900012", "K851207", "K895673", "K250404", "K900142", "K152675", "K810671", "K900140", "K871154", "K903869", "K152129", "K812802", "K972731", "K900008", "K852678", "K791722", "K803300", "K902526", "K896761", "K896764", "K151620", "K902451", "K915628", "K870626", "K173651", "K871155", "K771482", "K124024", "K214016", "K921052", "K893231", "K900226", "K900243", "K895631", "K871050", "K892872", "K791426", "K812130", "K791899", "K883239", "K860700", "K231849", "K961825", "K083542", "K810840", "K896763", "K974387", "K963668", "K873984", "K915304", "K896956", "K801881", "K900141", "K900323", "K810670", "K792651", "K871049", "K801193", "K930843", "K192705" ], "registration_number": [ "8030639", "8030665", "3038277270", "1650907", "1649518", "1019003", "3038195011", "2314912", "3013188547", "3016096143", "3005941719", "1225714", "3003504604", "3039353681", "9612168", "3032828299", "3002907620", "3015335038", "9680579", "9611823", "1058584", "3004111573", "3035708507" ], "fei_number": [ "1000219637", "3001236277", "3038277270", "3002806471", "1019003", "3002681132", "3038195011", "2314912", "3013188547", "3002807005", "3002807744", "3016096143", "1000203464", "6898", "3003504604", "3002807111", "3039353681", "3001451489", "3032828299", "3002907620", "3015335038", "3004111573", "3035708507" ], "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5630", "device_class": "2" } } ] }