OptumHealth Care Solutions LLC recalls Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

Recall date

April 18, 2024

Source

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

Recall number

Z-1811-2024

FDA classification

Class I

Brand / firm

OptumHealth Care Solutions LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.

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

Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump