Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The pump offers a variety of delivery modes programmable to meet specific patient care needs.

FDA Recall Z-0610-2020 · Posted 2019-12-12

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2019-10-28
Date Terminated2024-06-06
Product Quantity626 devices

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.

Firm 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. Questions can be directed to [email protected].

Root Cause

Software design

Distribution Pattern

CO, MD, NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111386MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)Smiths Medical MD, Inc. · 2011-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑