{ "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": "139148", "product_res_number": "Z-0291-2016", "event_date_initiated": "2015-06-29", "event_date_posted": "2015-11-17", "recall_status": "Terminated", "event_date_terminated": "2017-01-24", "res_event_number": "71818", "product_code": "FKX", "k_numbers": [ "K102936" ], "product_description": "Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.", "code_info": "All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R.   Dates Distributed: 1994 to present  Quantity Distributed: All", "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": "Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.", "root_cause_description": "Device Design", "action": "Baxter sent an Important Product Information communication to affected customers (patients and clinicians) via U.S.P.S., first-class mail on June 29, 2015. The letter states that Baxter Healthcare Corporation is updating the HomeChoice Patient At-Home Guide to include a discussion of the expected operating sounds associated with the HomeChoice and HomeChoice PRO devices. The new labeling will address the following:\r\nThe HomeChoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the HomeChoice cycler. There will be sounds like humming, swishing, clicking, and venting (air being released) that are normal for the operation of the cycler. In certain portions of the therapy, the sound level is expected to increase which is also part of normal operation. If there is a significant change in the sound level or a new, previously unheard sound when using the HomeChoice cycler, please contact your doctor and/or nurse or Baxter Technical Services. \r\n\r\nThe firm advises customers to keep the letter with the Patient At-Home Guide.\r\nThe firm also requests that customers complete the enclosed home patient reply form (enclosure) and return it to Baxter by faxing the reply form to 224-270-5457, scanning and e-mailing it to fca@baxter.com or by mail in the enclosed, preaddressed, stamped envelope. Returning the home patient reply form promptly will prevent you from receiving repeat notices. \r\n\r\nIf the customer has any questions about their Peritoneal Dialysis (PD) therapy, they are advised to please contact their doctor and/or nurse.\r\n\r\nAdditionally the letter states that any adverse reactions or quality problems experienced with the use of this product may be reported using one of the following options:\r\n\" Calling Baxter Product Surveillance at 800-437-5176, Monday through Friday, between 8:00 am and 5:30 pm Central Time\r\n Baxter will advise customers of the additional product information regarding", "product_quantity": "29355", "distribution_pattern": "Nationwide Distribution, District of Columbia, and Puerto Rico.", "openfda": { "k_number": [ "K910173", "K833749", "K771484", "K822546", "K842305", "K124018", "K012988", "K772150", "K933687", "K181108", "K841929", "K831766", "K935659", "K173718", "K823330", "K823303", "K250523", "K201867", "K884554", "K874632", "K243371", "K830881", "K002892", "K212658", "K923065", "K822549", "K102936", "K830208", "K053512", "K844144", "K823777", "K220935", "K833065", "K823217", "K994218", "K833595", "K832141", "K901477", "K141145", "K850406", "K842885", "K810683", "K845042", "K822712", "K823827", "K862928", "K822025", "K840224", "K830257", "K822658", "K822361", "K844630", "K872652", "K822545", "K902149", "K811986", "K823331", "K791342", "K830689", "K830766", "K823296", "K043363", "K820179", "K905809", "K103220", "K222318", "K822550", "K901228", "K822547", "K823390", "K151525", "K844108", "K823857", "K123630", "K831716", "K813487", "K822543", "K901478", "K171652", "K822548", "K212522", "K895336", "K822544" ], "registration_number": [ "3012536737", "", "8030665", "3012494290", "3038277270", "1650907", "1721676", "9610270", "3010421104", "3004111573", "2133641", "3031565407", "1649518", "9612052", "3038195011", "2314912", "3003537036", "3033589330", "1724474", "3006194679", "1225714", "2030624", "9680340", "3003504604", "3030306055", "1319639", "3015225571", "3039353681", "1721504", "3015309643", "3015882716", "3032828299", "3006950086", "3002907620", "3006755813", "2132111", "3015335038", "9680579", "9612057", "8030638", "3003865400" ], "fei_number": [ "3012536737", "", "1000434163", "3001236277", "3012394756", "3012494290", "1000138054", "3038277270", "1721676", "3010421104", "3031565407", "3002806443", "3002681132", "3038195011", "2314912", "3003537036", "3033589330", "3002807744", "3006194679", "3002806460", "1000203464", "3003504604", "3030306055", "1000140026", "3015225571", "3039353681", "1721504", "3002806727", "3015309643", "3001451489", "3015882716", "3032828299", "3006950086", "3002907620", "3006755813", "3003094851", "3015335038", "3000203466", "3000206435", "3004111573", "3003865400" ], "device_name": "System, Peritoneal, Automatic Delivery", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5630", "device_class": "2" } } ] }