Z-1811-2024Class I

Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

Name: Z-1811-2024 Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Creator: OptumHealth Care Solutions LLC
Published: 2024-04-18
License: https://open.fda.gov/license/

Optum Distribution Center, LLC / initiated 2024-04-18 / Open, Classified / root cause: design

FDA source

OptumHealth Care Solutions LLC began a recall of Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump on 2024-04-18. FDA classified it as Class I and gives the reason as "Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1811-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-05-21
Recalling firm: Optum Distribution Center, LLC
Product: Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Product code: FRN Pump, Infusion
Reason for recall: Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the 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.
Root cause tag: design
FDA root cause: Device Design
Action: Optumhealth Care Solutions, LLC issued an Urgent Device Recall by the Manufacturer of Nimbus II Pump notice to its consignees on 04/18/2024 via email Delivery/Adobe Sign and UPS Next Day Air. The notice sent an electronic link to the press release and stated that a nurse would be contacting the consignee to schedule a pump replacement, including a home visit to instruct the patient on the use of the new pump. In the meantime, if you have any issue with your current Nimbus II pump, please contact your nurse right away to prioritize your pump replacement. Additionally, the manufacturer recommends in its recall notice that you take the following actions, so please be aware and comply with them until your Nimbus II pump has been replaced: 1. When replacing batteries, only new batteries should be used. Care should be taken to ensure that old and new batteries are not confused when completing the replacement. 2. The battery should not be cycled (turned on/off) to clear the occlusion alarm. If the occlusion alarm cannot be cleared, a new pump should be used. Silencing the alarm does not clear the occlusion. 3. Due to the potential ambulatory use of the pump, you may carry the drug product dispensing pouch in a carrying pack. Please note that impeding the tubing set or placing pressure on the device (leaning against it, sitting on it) may cause the device to malfunction. 4. If you note any difficulties or abnormalities with the pump or accessories, immediately discontinue use of the pump and notify your Optum nurse or health care provider.
Quantity in commerce: 208 units
Distribution: US Nationwide Distribution
Product codes and lots: UDI/DI 00862492000308, Each unit has a Lot Number and a Serial Number, listed as follows: Lot Number/Serial Number: 302604 / NIMBP702231, 318050 / NIMBP715656, 340086 / NIMBS718475, 340163 / NIMBS716926, 340648 / NIMBS716122, 340746 / NIMBS715845, 340820 / NIMBS712929, 340903 / NIMBP719704, 341046 / NIMBS713994, 341372 / NIMBS718513, 341535 / NIMBS718700, 341757 / NIMBS716661, 341770 / NIMBS716996, 342136 / NIMBS715836, 342233 / NIMBS718503, 342350 / NIMBS714995, 342447 / NIMBS713444, 342938 / NIMBS716864, 343066 / NIMBS716125, 343309 / NIMBS719492, 343683 / NIMBS716506, 344023 / NIMBS716532, 344044 / NIMBS718477, 344173 / NIMBS718500, 344273 / NIMBS715037, 344407 / NIMBS709122, 344440 / NIMBS709111, 344450 / NIMBS708973, 344455 / NIMBS709568, 344572 / NIMBS709989, 344588 / NIMBS708676, 344692 / NIMBS709563, 344783 / NIMBS709112, 344853 / NIMBS709482, 344862 / NIMBS709556, 344976 / NIMBS709267, 345057 / NIMBS716989, 345060 / NIMBS716509, 345190 / NIMBS708707, 345195 / NIMBS719668, 345396 / NIMBS718671, 345397 / NIMBS708966, 345443 / NIMBS716367, 345446 / NIMBS719686, 345728 / NIMBS718488, 345732 / NIMBS716946, 345774 / NIMBS716166, 345872 / NIMBS709020, 345879 / NIMBS716159, 346002 / NIMBS716398, 346156 / NIMBS710038, 346167 / NIMBS709114, 346318 / NIMBS709337, 346410 / NIMBS715276, 346634 / NIMBS709569, 346636 / NIMBS709080, 346638 / NIMBS717005, 346642 / NIMBS716878, 346643 / NIMBS709550, 346947 / NIMBS709316, 347056 / NIMBS718701, 347173 / NIMBS716827, 347296 / NIMBS717651, 347304 / NIMBS708964, 347396 / NIMBS713609, 347526 / NIMBS716794, 347529 / NIMBS716803, 347534 / NIMBS718487, 347650 / NIMBS716650, 347654 / NIMBS716906, 347664 / NIMBS716952, 347665 / NIMBS716487, 347666 / NIMBS718494, 347799 / NIMBS716814, 347827 / NIMBS717661, 347828 / NIMBS718490, 347854 / NIMBS709506, 347856 / NIMBS706539, 347858 / NIMBS708541, 348023 / NIMBS715840, 348029 / NIMBS716933, 348032 / NIMBS717419, 348044 / NIMBS716161, 348150 / NIMBS716489, 348152 / NIMBS716507, 348159 / NIMBS716395, 348161 / NIMBS718657, 348251 / NIMBS715850, 348257 / NIMBS719132, 348358 / NIMBS709103, 348360 / NIMBS716999, 348447 / NIMBP719452, 348453 / NIMBS712917, 348535 / NIMBS717650, 348538 / NIMBS719666, 348598 / NIMBS716649, 348599 / NIMBS718672, 348605 / NIMBP719122, 348698 / NIMBS719665, 348704 / NIMBS716958, 348768 / NIMBS716929, 348770 / NIMBS717845, 348771 / NIMBS718687, 348822 / NIMBS709562, 348925 / NIMBS717642, 348926 / NIMBS716945, 348928 / NIMBS718685, 349012 / NIMBS709268, 349016 / NIMBS708438, 349043 / NIMBS708901, 349050 / NIMBS708930, 349076 / NIMBS708771, 349080 / NIMBS708617, 349131 / NIMBS709233, 349132 / NIMBS708612, 349147 / NIMBS708812, 349148 / NIMBS709155, 349151 / NIMBS709143, 349195 / NIMBS708753, 349242 / NIMBS709958, 349247 / NIMBS715726, 349281 / NIMBS716660, 349283 / NIMBS708623, 349329 / NIMBS719707, 349337 / NIMBS715730, 349338 / NIMBS716951, 349339 / NIMBS707669, 349429 / NIMBP707727, 349434 / NIMBS708976, 349454 / NIMBS719462, 349509 / NIMBS709794, 349562 / NIMBS718501, 349565 / NIMBS718699, 349566 / NIMBS719692, 349613 / NIMBS709124, 349707 / NIMBS708968, 349785 / NIMBS718666, 349786 / NIMBS718684, 349787 / NIMBS708998, 349911 / NIMBS714990, 349912 / NIMBS708068, 349914 / NIMBS718509, 350073 / NIMBS716807, 350077 / NIMBS707032, 350081 / NIMBS709119, 350083 / NIMBS708884, 350086 / NIMBS716950, 350087 / NIMBS716179, 350174 / NIMBS718682, 350175 / NIMBP703889, 350179 / NIMBS718695, 350208 / NIMBS709025, 350209 / NIMBS708937, 350211 / NIMBS709475, 350214 / NIMBS718667, 350216 / NIMBS719472, 350217 / NIMBS718677, 350270 / NIMBP715002, 350387 / NIMBS708659, 350388 / NIMBS719695, 350389 / NIMBS709065, 350516 / NIMBS718673, 350605 / NIMBS708437, 350698 / NIMBS708198, 350834 / NIMBS708807, 350835 / NIMBS708609, 350837 / NIMBS708916, 350838 / NIMBS709097, 350843 / NIMBS708750, 350845 / NIMBS716153, 350846 / NIMBS716150, 350847 / NIMBS716871, 350849 / NIMBS716986, 350851 / NIMBS713751, 350852 / NIMBS715994, 350854 / NIMBS708816, 350855 / NIMBS713878, 350856 / NIMBS716833, 350857 / NIMBS715015, 350860 / NIMBP719679, 350867 / NIMBS718492, 350868 / NIMBS716164, 350870 / NIMBS714987, 350886 / NIMBS715741, 350888 / NIMBS717664, 350889 / NIMBS709244, 350890 / NIMBS709436, 350891 / NIMBS718680, 350892 / NIMBS708427, 350893 / NIMBS708667, 350894 / NIMBS717652, 350895 / NIMBS718498, 350896 / NIMBS716949, 350897 / NIMBS717658, 350899 / NIMBS716914, 351697 / NIMBS719678, 351699 / NIMBS708735, 351701 / NIMBS716931, 351702 / NIMBS709326, 351703 / NIMBS718473, 351704 / NIMBS716400, 351715 / NIMBS708604, 351717 / NIMBS709269, 351720 / NIMBS709148, 351722 / NIMBS709473, 351723 / NIMBP716638, 351725 / NIMBS709060, 351898 / NIMBS718689.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1811-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1811-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-05-29	2024-05-20

Product code FRN

K153193Class IIHalo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)Zyno Medical, LLC / cleared 2016-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)