{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94220", "product_res_number": "Z-0103-2011", "event_date_initiated": "2010-09-03", "event_date_posted": "2010-10-20", "recall_status": "Terminated", "event_date_terminated": "2023-02-16", "res_event_number": "56675", "product_code": "FKX", "k_numbers": [ "K043363" ], "product_description": "LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212, manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.", "code_info": "Lot Number Expiration Date 09AR08026 \t1/31/2012 09AR08045 \t1/31/2012 09AR08046 .\t 11/30/2011  09AR08092 \t1/31/2012 09AR08093 \t1/31/2012 09AR08103 \t1/31/2012 09AR08104\t 01/31/2012 09AR08119 \t11/30/2011 09BR08034\t 02/29/2012 09BR08035 \t2/29/2012 09BR08036\t 02/29/2012  09BR08037 \t2/29/2012 09BR08038\t 02/29/2012  09BR08050 \t2/29/2012 09BR08051 \t02129/2012  09BR08052 \t02129/2012 09BR08073\t 02129/2012  09BR08074 \t2/29/2012 09BR08801 \t02/29/2012  09BR08802\t 02/29/2012  09BR08803 \t2/29/2012 09CR08018 \t3/31/2012 09CR08019 \t3/31/2012 09CR08032 \t3/31/2012 09CR08033\t 03/31/2012   09CR08034 \t3/31/2012 09CR08035 \t3/31/2012  09CR08095 \t3/31/2012  09DR08001 \t4/30/2012 09DR08002\t 04/30/2012  09DR08023 \t4/30/2012 09DR08037 \t4/30/2012 09DR08039 \t4/30/2012 09DR08040 \t04130/2012   09ER08093 \t05131/2012  09ER08094\t 05131/2012  09ER08095 \t05131/2012 09ER08096 \t05131/2012  09ER08097 \t5/31/2012 09ER08104\t 05/31/2012 09HR08072\t 06/30/2012 09HR08073 \t6/30/2012 09HR08074\t 06/30/2012 09HR08099\t 06/30/2012 09HR08100\t 06/30/2012 09HR08101 \t6/30/2012  09HR08130\t 06/30/2012 09HR08131\t 06/30/2012 09JR08016\t 07/31/2012 09JR08017\t 07/31/2012 09JR08018\t 07/31/2012 09JR08019 \t7/31/2012 09JR08095\t 07131/2012 09JR08096\t 07131/2012 09JR08097\t713112012  09JR08106 \t713112012 09KR08007 \t813112012", "firm_fei_number": "3001451489", "recalling_firm": "Fresenius Medical Care Holdings, Inc.", "address_1": "920 Winter St", "city": "Waltham", "state": "MA", "postal_code": "02451-1521", "additional_info_contact": "Kathleen Storro\n800-662-1237", "reason_for_recall": "Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.", "root_cause_description": "Nonconforming Material/Component", "action": "Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.", "product_quantity": "363,265 units", "distribution_pattern": "Nationwide Distribution: Throughout USA.", "openfda": { "k_number": [ "K053512", "K830766", "K830881", "K901228", "K212522", "K822543", "K935659", "K844108", "K103220", "K823217", "K171652", "K823296", "K862928", "K822712", "K822361", "K820179", "K831766", "K874632", "K791342", "K830689", "K840224", "K822548", "K012988", "K811986", "K901477", "K043363", "K250523", "K842885", "K222318", "K842305", "K905809", "K813487", "K895336", "K822544", "K872652", "K823331", "K844144", "K841929", "K823390", "K102936", "K910173", "K850406", "K831716", "K771484", "K220935", "K884554", "K822658", "K151525", "K141145", "K845042", "K124018", "K994218", "K844630", "K901478", "K772150", "K830208", "K833065", "K123630", "K822550", "K822545", "K201867", "K832141", "K830257", "K923065", "K823827", "K823303", "K833749", "K833595", "K822549", "K933687", "K810683", "K212658", "K823777", "K181108", "K823857", "K822546", "K822025", "K822547", "K173718", "K002892", "K823330", "K243371", "K902149" ], "registration_number": [ "", "3033589330", "3015225571", "1225714", "3012494290", "2030624", "3002907620", "9610270", "1319639", "2314912", "3030306055", "8030665", "1724474", "3038195011", "3003537036", "3006755813", "1721504", "3004111573", "9680579", "2132111", "3031565407", "3006950086", "3010421104", "3015335038", "9612052", "3015882716", "3006194679", "3038277270", "2133641", "9612057", "8030638", "3003504604", "3012536737", "9680340", "3015309643", "3003865400", "1650907", "3032828299", "3039353681", "1721676", "1649518" ], "fei_number": [ "", "3033589330", "3002806460", "3015225571", "3012494290", "3002681132", "3001236277", "3002807744", "3002907620", "2314912", "3030306055", "3038195011", "3003537036", "3006755813", "1721504", "3004111573", "3002806727", "3031565407", "3001451489", "3006950086", "3010421104", "1000203464", "3015335038", "3003094851", "3015882716", "3012394756", "3006194679", "3038277270", "1000434163", "3000203466", "1000138054", "3003504604", "3012536737", "3015309643", "3003865400", "1000140026", "3000206435", "3032828299", "3039353681", "3002806443", "1721676" ], "device_name": "System, Peritoneal, Automatic Delivery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5630", "device_class": "2" } } ] }