Class I

Medical Device Recall: Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump

OptumHealth Care Solutions LLC · April 18, 2024

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

States Affected

NATIONWIDE

Quantity Affected

208 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1811-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

OptumHealth Care Solutions LLC Medical Device Recall: Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump | SafeCheck