{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "177807", "product_res_number": "Z-0610-2020", "event_date_initiated": "2019-10-28", "event_date_posted": "2019-12-12", "recall_status": "Terminated", "event_date_terminated": "2024-06-06", "res_event_number": "84232", "product_code": "FRN", "k_numbers": [ "K111386" ], "product_description": "Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. 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Halverson\n763-383-3072", "reason_for_recall": "There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption of therapy.", "root_cause_description": "Software design", "action": "An Urgent Medical Device recall letter dated 10/28/2019 was sent to customers via email beginning 10/28/2019. The letter identified affected product, stated the issue, and provided instructions for customers to return the pumps. A response form was asked to be returned. 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