Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Reported: May 29, 2024 Initiated: April 18, 2024 #Z-1811-2024
Product Description
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.
Details
- Recalling Firm
- OptumHealth Care Solutions LLC
- Units Affected
- 208 units
- Distribution
- US Nationwide Distribution
- Location
- Marietta, GA
Frequently Asked Questions
What product was recalled? ▼
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump. Recalled by OptumHealth Care Solutions LLC. Units affected: 208 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 29, 2024. Severity: Critical. Recall number: Z-1811-2024.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11