FDA recall Z-1811-2024

Product

Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

Reason for recall

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.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2024-04-18

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2024