FDA-Device2024-04-03Class I
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
InfuTronix LLC
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.
Sold states
Domestic US distribution nationwide. No international distribution.
Affected count
52,328 total
Manufactured in
177 Pine St, N/A, Natick, MA, United States
Products
Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1286-2024Don't want to check this manually?
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