The Recall Desk
SevereFDA (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.

What this means for you

Illness, injury, or structural failure has been reported. 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
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 →

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