# FDA recall Z-2635-2023

> **Fresenius Kabi USA, LLC** · Class II · device recall initiated 2022-04-22.

## Product

Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1  Part Number: LVP-SW-0004.     Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

## Reason for recall

Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

## Distribution

US Nationwide distribution in the states of NJ, WI.

## Key facts

- **Recall number:** Z-2635-2023
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-04-22
- **Report date:** 2023-10-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Andover, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2635-2023

## Citation

> AI Analytics. FDA recall Z-2635-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2635-2023. Source: US FDA. Licensed CC0.

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