{ "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": "48483", "product_res_number": "Z-0169-2007", "event_date_initiated": "2006-09-06", "event_date_posted": "2006-11-14", "recall_status": "Terminated", "event_date_terminated": "2006-12-20", "res_event_number": "36361", "product_code": "KDI", "k_numbers": [ "K992894" ], "product_description": "Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.", "code_info": "all serial numbers", "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": "The Meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.", "root_cause_description": "Other", "action": "Urgent Device Correction letters dated 9/6/06 were sent to the Meridian accounts on the same date via UPS second day, to the attention of the Hemodialysis Administrator. The letters informed the accounts of the potential risk associated with a post-pump bloodline kink when using pre-pump arterial pressure monitoring. The accounts were provided with a revised Meridian Operator''s Manual which includes the following warnings: 'The lower venous limit should be set as close to the currently displayed venous pressure as conditions allow.' and 'Reliance on the pressure alarms should not substitute for clinical monitoring of the patient for adverse events.' Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 2. General questions were directed to The Center for One Baxter at 1-800-422-9837.", "product_quantity": "2,823 units", "distribution_pattern": "Nationwide and Hong Kong, Korea and China", "openfda": { "k_number": [ "K926568", "K982926", "K021615", "K034064", "K160444", "K844790", "K023874", "K013733", "K252377", "K232776", "K992564", "K131935", "K811944", "K000028", "K211370", "K043244", "K193005", "K062922", "K123288", "K112314", "K926373", "K070222", "K203062", "K970446", "K051520", "K150708", "K062090", "K122343", "K000724", "K883407", "K830487", "K870724", "K911094", "K032356", "K050727", "K830596", "K980386", "K973322", "K980859", "K840680", "K093069", "K854309", "K852885", "K900918", "K873887", "K010985", "K003023", "K050609", "K823589", "K113023", "K001422", "K233335", "K062079", "K854586", "K945621", "K190910", "K790827", "K801731", "K872767", "K082515", "K945747", "K210661", "K212216", "K070643", "K823881", "K090682", "K002277", "K884326", "K201809", "K950522", "K890315", 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