FDANovember 14, 2025device
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
What to do
FDA enforcement status: Ongoing
Brands named
fresenius kabifresenius
UPCs
00811505030122
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEpinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)2026-05-14
- FDABicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;2026-05-12
- FDABicarby Dialysate; Model number: RFP-400-G;2026-05-07
- FDAIvenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-00042026-05-06
- FDALVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.2026-05-06
- FDADELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.2026-04-06
- FDADELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.2026-04-06
- FDA0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale NDC Number: 65219-466-60.2026-03-11
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