Home / Recalls / Fresenius Kabi USA, LLC / Z-0586-2026

Z-0586-2026 Class I Ongoing

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

FDA device recall Z-0586-2026 was initiated by Fresenius Kabi USA, LLC on November 3, 2025 and is designated Class I. Reason for recall: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. The recall status is ongoing. Affected quantity: 483 cases (12,075 eaches).

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: 483 cases (12,075 eaches)

Product Description

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

Reason for Recall

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Distribution Pattern

US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.

Code Information

Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.

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)