Nimbus Ambulatory Infusion Pump recalled due to multiple failure modes
InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the rubric. The recalled infusion pumps have multiple potential failure modes that could compromise medication delivery. No deaths or hospitalizations are reported in the source text.
Plain-English summary
InfuTronix LLC is recalling the Nimbus Administration Set, Nimbus Flex, and Nimbus PainPro ambulatory infusion pump systems due to potential failure modes including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, and damaged pump housing.
The recall affects approximately 52,328 units that have been distributed nationwide in the United States. The FDA has classified this as a Class I recall. InfuTronix is removing the devices from the market and will no longer provide device support or availability after June 20, 2024.
The recalled product
- Product
- Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
- Manufacturer
- InfuTronix LLC
- Affected units
- 52,328
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by InfuTronix LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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