Reported May 29, 2024 · Ongoing
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
OptumHealth Care Solutions LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OptumHealth Care Solutions LLC · 877 Franklin Gtwy Se · Marietta, GA · 30067-8029
Is this the product you have?
- Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
- Lot codes and dates
- UDI/DI 00862492000308, Each unit has a Lot Number and a Serial Number
- listed as followsLot
- Number/Serial Number
208 of 208 codes
302604 / NIMBP702231318050 / NIMBP715656340086 / NIMBS718475340163 / NIMBS716926340648 / NIMBS716122340746 / NIMBS715845340820 / NIMBS712929340903 / NIMBP719704341046 / NIMBS713994341372 / NIMBS718513341535 / NIMBS718700341757 / NIMBS716661341770 / NIMBS716996342136 / NIMBS715836342233 / NIMBS718503342350 / NIMBS714995342447 / NIMBS713444342938 / NIMBS716864343066 / NIMBS716125343309 / NIMBS719492343683 / NIMBS716506344023 / NIMBS716532344044 / NIMBS718477344173 / NIMBS718500344273 / NIMBS715037344407 / NIMBS709122344440 / NIMBS709111344450 / NIMBS708973344455 / NIMBS709568344572 / NIMBS709989344588 / NIMBS708676344692 / NIMBS709563344783 / NIMBS709112344853 / NIMBS709482344862 / NIMBS709556344976 / NIMBS709267345057 / NIMBS716989345060 / NIMBS716509345190 / NIMBS708707345195 / NIMBS719668345396 / NIMBS718671345397 / NIMBS708966345443 / NIMBS716367345446 / NIMBS719686345728 / NIMBS718488345732 / NIMBS716946345774 / NIMBS716166345872 / NIMBS709020345879 / NIMBS716159346002 / NIMBS716398346156 / NIMBS710038346167 / NIMBS709114346318 / NIMBS709337346410 / NIMBS715276346634 / NIMBS709569346636 / NIMBS709080346638 / NIMBS717005346642 / NIMBS716878346643 / NIMBS709550346947 / NIMBS709316
- Amount recalled
- 208 units
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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