FDAFebruary 21, 2024device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
infutronix
UPCs
00817170020086008171700200930081717002016100817170020376008171700201090081717002001700817170020048008171700200240081717002003100817170020123
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDANimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components2024-02-21
- FDANimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and IT1077-DUKE-HSP2021-10-19
- FDANimbus Administration Set, REF HS-004, UDI # 00817170020031 Product Usage: Administer fluids/medication from a container to a patient through a needle or a catheter.2019-05-28
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