Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Enforcement
- Recall Number
- Z-1811-2024
- Event ID
- 94491
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- OptumHealth Care Solutions LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- May 29, 2024
- Initiation Date
- April 18, 2024
- Classification Date
- May 20, 2024
- Address
- 877 Franklin Gtwy Se, Marietta, GA, 30067-8029, United States
Description
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
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.
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.
US Nationwide Distribution
208 units