OptumHealth Care Solutions LLC: Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

Recall number

Z-1811-2024

Recalling firm

OptumHealth Care Solutions LLC

Product

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

Status

Open, Classified

Initiated

2024-04-18

Posted

2024-05-21

Terminated

not on file

Reason

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

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

208 units

Distribution

US Nationwide Distribution

Lot, serial or model codes

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.

510(k) numbers

["K153193"]

PMA numbers

not on file

Product code

FRN

Firm FEI

3009456923

Firm city

Marietta

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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