Agency classClass IOur severity:Severe FDA (Devices)·Z-1286-2024·Announced 2024-04-03

Nimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures

InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.

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: This is an FDA Class I recall, which per the severity rubric establishes a minimum score of 4 (Severe). Although no illnesses or injuries have been reported to date, the multiple critical failure modes identified—including battery failure, drug product leakage, and flow rate malfunctions—pose serious potential for patient harm in an infusion pump system that directly delivers medication.

Plain-English summary

InfuTronix LLC is recalling the Nimbus II Infusion System, a line of ambulatory infusion pumps used to deliver medication to patients. The recall includes multiple models: Nimbus II PainPRO (IT1053), Nimbus II Flex (IT1062), Nimbus II Plus (IT1078), Nimbus II EpiD (IT1124), and Nimbus II EMS (IT1063), along with their related administration sets. A total of 52,328 units have been distributed nationwide in the United States.

The pumps are being recalled due to multiple potential failure modes that could compromise safe device operation. The identified failure modes include battery failure, upstream occlusion, system errors, drug product leakage, abnormal flow rates (either too high or too low), and damage to the pump housing.

InfuTronix has discontinued support and production for these devices. The pumps will not be available or supported after June 20, 2024. Patients and healthcare providers should be aware of this discontinuation date.

The recalled product

Product: 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
Manufacturer: InfuTronix LLC
Category: Medical Device — Ambulatory Infusion Pump
Hazard: battery-failure
system-error
drug-leakage
flow-rate-malfunction
device-damage
occlusion
Affected units: 52,328

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

UDI-DI: Nimbus II PainPRO: UDI-DI 00817170020086
Nimbus II EpiD: UDI-DI 00817170020376 Lot ALZ103-200824420
Nimbus II EMS: UDI-DI 00817170020109 Lots AGZ057-170925120 AGZ057-171027300

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 →

Same manufacturer · InfuTronix LLC

See all →

Severe
Nimbus Ambulatory Infusion Pump recalled due to multiple failure modes
FDA (Devices) · 2024-04-03
High
Ambulatory infusion pumps recalled due to erroneous software installation
FDA (Devices) · 2022-04-06
High
InfuTronix Nimbus Administration Set Recalled for Potential Tube Leakage
FDA (Devices) · 2019-07-31

Same hazard · battery failure