OptumHealth Care Solutions LLC: Device Recall
Recall #Z-1811-2024 · 04/18/2024
Class I: Dangerous
Recall Details
- Recall Number
- Z-1811-2024
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- OptumHealth Care Solutions LLC
- Status
- Ongoing
- Date Initiated
- 04/18/2024
- Location
- Marietta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 208 units
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.
Product Description
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Distribution Pattern
US Nationwide Distribution
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.