Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reported: December 24, 2025 Initiated: November 14, 2025 #Z-0885-2026
Product Description
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason for Recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 30 units
- Distribution
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.. Recalled by Fresenius Kabi USA, LLC. Units affected: 30 units.
Why was this product recalled? ▼
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 24, 2025. Severity: Critical. Recall number: Z-0885-2026.
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