Smiths Medical ASD Inc. recalls Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portable syringe infusion pump. The…

Recall date

October 28, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0610-2020

FDA classification

Class I

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

CO, MD, NY

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.