FDAFDA · Alimentos y medicamentos·N.º oficial Z-1811-2024
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Publicado el 29 de mayo de 2024 · Inicio del retiro: 18 de abril de 2024
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- OptumHealth Care Solutions LLC
- Distribuidor
- US Nationwide Distribution
- Lote
- 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 / N
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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