Home / Recalls / Fresenius Kabi USA, LLC / Z-0848-2026

Z-0848-2026 Class II Ongoing

Recalled by Fresenius Kabi USA, LLC — North Andover, MA

FDA device recall Z-0848-2026 was initiated by Fresenius Kabi USA, LLC on November 3, 2025 and is designated Class II. Reason for recall: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. The recall status is ongoing. Affected quantity: 15,862 units.

Recall Details

Product Type: Devices
Report Date: December 10, 2025
Initiation Date: November 3, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 15,862 units

Product Description

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Reason for Recall

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Distribution Pattern

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

Code Information

Model Number: LVP-0004. UDI-DI: 00811505030320.

Other recalls by Fresenius Kabi USA, LLC

D-0581-2026 Class III — Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka (May 14, 2026)
Z-2224-2026 Class I — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 (May 6, 2026)
Z-2223-2026 Class I — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. (May 6, 2026)
D-0435-2026 Class II — 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL free (March 11, 2026)
D-0425-2026 Class II — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, (March 11, 2026)
D-0431-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a (March 11, 2026)
D-0437-2026 Class II — 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL f (March 11, 2026)
D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)
D-0432-2026 Class II — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a (March 11, 2026)
D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)