Optum Nimbus II Plus Infusion Pump Recall Due to Potential Failure Modes
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies to medical devices with an imminent health hazard. While no illnesses or deaths are reported, the multiple potential failure modes—battery failure, system errors, drug leakage, and abnormal flow rates—in an infusion pump could compromise medication delivery and patient safety.
Plain-English summary
OptumHealth Care Solutions LLC is recalling the Optum Nimbus II Plus, Model AAA-00170, an ambulatory infusion pump used to deliver medication. This recall affects 208 units distributed nationwide in the United States.
The pump is being recalled due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, abnormal flow rates, and damaged pump housing. These failures could affect the safe and accurate delivery of medications to patients.
Patients and healthcare providers should verify whether their device matches one of the recalled lot numbers and serial numbers listed in the FDA recall notice. Affected individuals should contact the manufacturer, OptumHealth Care Solutions LLC, for guidance on next steps regarding their specific device.
The recalled product
- Product
- Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
- Manufacturer
- OptumHealth Care Solutions LLC
- Hazard
- battery-failure
- upstream-occlusion
- system-error
- drug-leakage
- abnormal-flow-rate
- housing-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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