{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "31720", "product_res_number": "Z-0584-04", "event_date_initiated": "2004-02-20", "event_date_posted": "2004-07-20", "recall_status": "Terminated", "event_date_terminated": "2008-02-26", "res_event_number": "28375", "product_code": "KDI", "k_numbers": [ "K030099" ], "product_description": "Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.", "code_info": "Serial numbers 300001 through 300147", "firm_fei_number": "3000210122", "recalling_firm": "Baxter Healthcare Renal Div", "address_1": "1620 Waukegan Rd Bldg R Mc Gaw", "city": "Park", "state": "IL", "postal_code": "60085-6730", "additional_info_contact": "Center for One Baxter\n800-422-9837", "reason_for_recall": "These devices have the potential to overheat in the absence of a Ground Fault Circuit Interrupter (GFCI). This heater system failure could result in a fire.", "root_cause_description": "Other", "action": "Baxter sent urgent device correction letters dated 2/20/04 to the Hemodialysis Unit Administrators on the same date. The letters informed the accounts of the potential of a heater system failure that under specific conditions could lead to a fire. The letters listed the concurrent conditions that must exist for the potential overheating, and recommended that the following steps be taken to ensure the safety in operating the devices: 1) Plug these machine into GFCI outlets if available, and 2) If GFCI outlets are not available at the facility, the machines must be 'hard-powered off' after dialysis treatments are complete at the end of the day. The machine is had-powered off by placing the main power switch located in the back of the machine into the OFF position. If the facility typically performs a heat clean cycle of machines after treatments are completed, it is imperative that the machines are hard powered off at the completion of the cycle. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 1, Monday through Friday, 8:30 AM to 6:00 PM EST.", "product_quantity": "130 units", "distribution_pattern": "The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Lebanon, Morocco, Malaysia, the Netherlands, Oman, Panama, Preu, Philippines, Poland, Palestine, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and United Kingdom.", "openfda": { "k_number": [ "K926568", "K982926", "K021615", "K034064", "K160444", "K844790", "K023874", "K013733", "K252377", "K232776", "K992564", "K131935", "K811944", "K000028", "K211370", "K043244", "K193005", "K062922", "K123288", 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"3007137787", "3015349756", "3014279513" ], "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5860", "device_class": "2" } } ] }