{ "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": "204472", "product_res_number": "Z-0549-2024", "event_date_initiated": "2023-11-29", "event_date_posted": "2023-12-20", "recall_status": "Open, Classified", "res_event_number": "93474", "product_code": "FRN", "k_numbers": [ "K183311" ], "product_description": "Ivenix Infusion System (IIS), Large Volume Pump LVP-0004", "code_info": "UDI-DI 00811505030320\n\nSerial 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"firm_fei_number": "3014732157", "recalling_firm": "Fresenius Kabi USA, LLC", "address_1": "50 High St Ste 50 50 High St", "address_2": "Ste 50", "city": "North Andover", "state": "MA", "postal_code": "01845-2620", "additional_info_contact": "Customer Support\n978-775-8100", "reason_for_recall": "The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.", "root_cause_description": "Process change control", "action": "On November 29, 2023, the firm began notifying affected customers via\" URGENT-Medical Device Recall\" letter dated November 28, 2023.\n\nCustomers were provided with precautions to take until the affected LVPs are able to be returned for repair or replacement of internal hardware.\n\nCustomers will be contacted by a Fresenius Kabi service representative to create a plan for addressing any affected LVPs at their facility. This effort is expected to begin in January 2024. Fresenius Kabi will repair LVPs that may encounter mechanical interference causing the Fluid Valve Actuation System not to move properly. If the LVP cannot be repaired, it will be replaced at no cost to the customer.\n\nIf you have any questions contact Customer support at, email: Ivenix_support@fresenius-kabi.com or phone at 1-978-775-8100.", "product_quantity": "938 US", "distribution_pattern": "US distribution to states of: CA, CO, NJ, UT, and WI.", "openfda": { "k_number": [ "K983005", "K990101", "K050433", "K913931", "K961703", "K842421", "K222048", "K844730", "K830102", "K091855", "K100705", "K841630", "K841922", "K844792", "K830038", "K923875", "K800629", "K853814", "K923601", "K780086", "K071545", "K214045", "K831259", "K041550", "K983321", "K854074", "K844091", "K232793", "K820073", "K880569", "K875348", "K915646", "K843548", "K042432", "K870992", "K833983", "K873875", "K910350", "K913907", "K953660", "K894506", "K882107", "K831534", "K842027", "K855215", "K843772", "K900375", "K915407", "K042609", "K123049", "K952967", "K901755", "K924867", "K870991", "K023491", "K172831", "K944669", "K900057", "K792050", 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