{ "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": "196592", "product_res_number": "Z-0272-2023", "event_date_initiated": "2022-10-10", "event_date_posted": "2022-11-21", "recall_status": "Open, Classified", "res_event_number": "91052", "product_code": "FRN", "k_numbers": [ "K111386" ], "product_description": "Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment.\n\nUsed for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.", "code_info": "Model Number: 4000; Product Codes: 4000-0106-00 and 4000-0106-01\nUDI: 501951706962; 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Serial #'s \n2028673\n2044037\n2020917\n2032957\n2037477\n2040070\n2041392\n2041527\n2041668\n2049487\n2006685\n2006717\n2006750\n2008582\n2008620\n2047401\n2049022\n2049927\n2049932\n2049934\n2049941\n2060111\n2060405\n2060441\n2061199\n2067962\n2067977\n2067988", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "763-383-3072", "reason_for_recall": "Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump and documentation", "root_cause_description": "Under Investigation by firm", "action": "Smiths Medical notified consignees initially via telephone on 10/10/2022 and followed up with a letter via email on 10/11/2022. The letter was titled \"URGENT MEDICAL DEVICE CORRECTION\" and instructed consignees to locate all affected pumps and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations, complete and return the attached Response Form to fieldactions@smiths-medical.com, and if Smiths Medical does not contact you to schedule the implementation of the software updates, please contact Smiths Medical Technical Assistance. \n\nFor further inquiries, please contact Smiths Medical using the following information:\nemail: MedfusionFieldCorrections@icumed.com.", "product_quantity": "422 devices", "distribution_pattern": "US distribution to states of: Indiana, Texas and Virginia", "openfda": { "k_number": [ "K062699", "K832285", "K211125", "K844730", "K880733", "K905783", "K924869", "K943692", "K903787", "K811272", "K942378", "K973593", "K933545", "K974332", "K895709", "K232793", "K904518", "K061108", "K965230", "K921050", "K924870", 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