OptumHealth Care Solutions LLC: Medical Device Recall in 2024 - (Recall #: Z-1811-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: April 18, 2024

Date Posted: May 29, 2024

Recall Number: Z-1811-2024

Event ID: 94491

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.

Status: Ongoing

Product Quantity: 208 units

Code Information:

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.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated