InfuTronix LLC recalls Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025.…

Recall date

February 21, 2024

Source

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

Recall number

Z-1285-2024

FDA classification

Class I

Brand / firm

InfuTronix LLC

Sold / distributed

Domestic US distribution nationwide. No international distribution.

Why it was recalled

InfuTronix is removing the Nimbus Infusion Pump Systems 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. The device will not be available or supported after June 20, 2024.

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

Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components