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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

InfuTronix LLC: Nimbus Infusion Pump Systems Recalled for Multiple Failure Risks

Agency Publication Date: March 28, 2024
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Summary

InfuTronix is recalling approximately 104,656 Nimbus Infusion Pump Systems, including the Nimbus Flex, PainPro, and Nimbus II models, because they are being removed from the market. These devices have multiple failure modes including battery failure, drug leakage, system errors, and incorrect flow rates. The manufacturer will stop supporting these devices after June 20, 2024, meaning they will no longer be available for use.

Risk

The pumps may fail to deliver medication accurately or stop working entirely due to battery or mechanical issues, which can lead to serious injury or death depending on the critical nature of the medication being infused.

What You Should Do

  1. Identify your device by checking the label for product names: Nimbus Administration Set, Nimbus Flex, Nimbus PainPro (Halo), Nimbus II PainPRO (IT1053), Nimbus II Flex (IT1062), Nimbus II Plus (IT1078), Nimbus II EpiD (IT1124), or Nimbus II EMS (IT1063).
  2. Check your device's UDI-DI and Lot numbers against the affected list, which includes UDI-DI 00817170020000 (Lots beginning with A100, AZ060), 00817170020086 (Lots beginning with AHZ081, AGZ049), and 00817170020093 among others listed in the recall.
  3. Transition patients to an alternative infusion system as soon as possible, as these devices will not be supported or available after June 20, 2024.
  4. Contact your healthcare provider if you have questions about your current treatment or if you experience any issues with the infusion pump.
  5. Contact InfuTronix LLC directly for instructions on how to return the device and to discuss potential remedies.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

📋Other Action

Removal from market and discontinuation of support.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo)
Model / REF:
Catalog Number IT1025
UPC Codes:
00817170020000
Lot Numbers:
A100-150205200
A100-150415015
A100-150430270
A100-150611300
A100-150716620
A100D-1705191000
AZ060-171201564
AZ060-1801021020
AZ060-180609264
AZ060-180626552
AZ060-190104792
AZ060-1902151200
A100F-160707073
A100F-160908250
A100F-161114700
Product: Nimbus II Infusion System (PainPRO, Flex, Plus, EpiD, EMS)
Model / REF:
IT1053
IT1062
IT1078
IT1124
IT1063
UPC Codes:
00817170020086
00817170020093
00817170020161
00817170020376
00817170020109
00817170020017
00817170020048
00817170020024
00817170020031
00817170020123
Lot Numbers (93):
AHZ081-190619096
AHZ081-200229480
AHZ081-2004171062
AHZ081-200517528
AHZ081-200714696
AHZ081-2009231440
AHZ081-201105480
AHZ081-201105360
AHZ081-201208288
AHZ081-2012081944
AHZ081-2108141920
AHZ081-211123360
AHZ081-2111242568
AHZ081-22062072
A100G-170420044
A100G-170512429
AGZ049-170512429
AGZ049-170615116
AGZ049-170816391
AGZ049-170829480
AGZ049-1709071188
AGZ049-171027828
AGZ049-1712011824
AGZ049-171229744
AGZ049-1806091272
AGZ049-180626984
AGZ049-1809201152
AGZ049-1810241536
AGZ049-181102108
AGZ049-190104504
AGZ049-190104648
AGZ049-190314768
AGZ049-1903151440
AGZ049-190515480
AGZ049-190515960
AGZ049-1906271440
AGZ049-1907231776
AGZ049-190723360
AGZ049-190806144
AGZ049-190924504
AGZ049-191023480
AGZ049-1912161920
AGZ049-200102576
AGZ049-2002251632
AGZ049-200714960
AGZ049-200828960
AGZ049-2009241440
AGZ049-2011301920
AGZ049-2103231200
AGZ049-210324360

Product Images

Nimbus Pump System Image

Nimbus Pump System Image

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94124
Status: Active
Manufacturer: InfuTronix LLC
Sold By: hospitals; medical clinics; specialized medical device distributors
Manufactured In: United States
Units Affected: 2 products (52,328 total)
Distributed To: Nationwide
Agency Last Updated: April 2, 2024

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.