FDA-Device2024-05-29Class I
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
OptumHealth Care Solutions LLC
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
208 units
Manufactured in
877 Franklin Gtwy Se, Marietta, GA, United States
Products
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2024Don't want to check this manually?
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