Fresenius Kabi USA, LLC

5 recalls on record

Class I — Urgent2025-12-03

Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Fresenius Kabi USA, LLCdrug

Class II2026-01-21

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Emphasizing instructions for LVP duration programming located in the IFU.

Fresenius Kabi USA, LLCdevice

Class I — Urgent2025-12-24

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Fresenius Kabi USA, LLCdevice

Class II2025-12-10

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

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

Fresenius Kabi USA, LLCdevice

Class I — Urgent2025-12-10

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.

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

Fresenius Kabi USA, LLCdevice