{ "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": "211456", "product_res_number": "Z-0763-2025", "event_date_initiated": "2024-12-06", "event_date_posted": "2025-01-08", "recall_status": "Open, Classified", "res_event_number": "95891", "product_code": "FRN", "k_numbers": [ "K183311" ], "product_description": "Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004", "code_info": "Model Number: LVP-0004, UDI Number: 00811505030320. \n\nSerial Numbers: 9233532106, 9233421830, 9233421828, 9233532158, 9233522076, 9233522041, 9233421833, 9233421829, 9233421808, 9233421654, 9233421626, 9233421621, 9233321340, 2215401517, 2215401545, 9233421789, 9233421809, 9233532167, 9233532100, 9233522070, 9233421825, 9233421824, 9233421794, 9233421783, 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9232750840, 9232190266.", "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": "978-775-8050", "reason_for_recall": "Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.", "root_cause_description": "Process control", "action": "Fresenius Kabi notified consignees on 12/06/2024 via \"URGENT - Medical Device Recall\" letter. Consignees were instructed to do the following: \n1. Review the facilities list of affected Serial Numbers and post the list in a public place. \n2. If an LVP exhibits a Pump Problem during use, remove the LVP from circulation, and notify Fresenius Kabi.\n3. Inform potential users of the product within your organization of this notification.\n4. Notify customers if product was further distributed.\n5. Complete and return the Customer Reply Form included in the letter to acknowledge receipt. \n\nCustomers will be contacted by a Fresenius Kabi service representative to create a plan for repairing any affected LVPs at your facility at no cost. Fresenius Kabi will also repair LVPs that may encounter pneumatic valve failures at no additional charge. \n\nFor customer support and questions, call 1-855-354-6387 normal hours are from Monday thru Friday 8:30am-5pm Easter Time, after hours supported by voicemail messaging or email: Ivenix_support@fresnius-kabi.com.", "product_quantity": "1,520 units", "distribution_pattern": "US distribution to states of: ID, MN, NV, TX, VA, 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", 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