FDA Device recall Z-1811-2024
Optum Nimbus II Plus, Model number AAA-00170
- FDA Device
- Class I
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class I recall of Optum Nimbus II Plus, Model number AAA-00170 by Optumhealth Care Solutions, citing 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, upstre….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1811-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-04-18 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Optumhealth Care Solutions |
| Distribution | US |
Product
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
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.
Identifiers
| code_info | UDI/DI 00862492000308, Each unit has a Lot Number and a Serial Number, listed as follows: Lot Number/Serial Number: 3…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, 34 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1811-2024%22
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