Official recall record

Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

US FDA — Medical Devices · 2023-11-29 · United StatesClass I

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2023-11-29
Country of alert: United States
Alert level: Class I
Alert type: recall
Barcode (EAN/GTIN): 00811505030320
Brand on record: Fresenius Kabi USA, LLC

What the authority reported

The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Same barcode in other registries

The same EAN appears in 6 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2025-11-03 · US FDA — Medical Devices
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
2024-12-06 · US FDA — Medical Devices
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
2023-03-10 · US FDA — Medical Devices
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
2025-09-03 · US FDA — Medical Devices
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
2026-02-04 · US FDA — Medical Devices
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Other recalls from this brand

2026-05-06 · US FDA — Medical Devices
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.