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InfuTronix LLC recalls Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT10
Recalled April 3, 2024 · FDA recall Z-1285-2024 · InfuTronix
Hazard
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. · FDA Class I
Units
52,328 total
Sold at
Domestic US distribution nationwide. No international distribution.
Description
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.
Product
Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
Manufacturer(s)
InfuTronix LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →