Fresenius Kabi USA, LLC: Device Recall

Recall #Z-1019-2025 · 01/10/2025

Class I: Dangerous

Recall Details

Recall Number
Z-1019-2025
Classification
Class I
Product Type
Device
Recalling Firm
Fresenius Kabi USA, LLC
Status
Ongoing
Date Initiated
01/10/2025
Location
North Andover, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
23 systems

Reason for Recall

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

Product Description

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Distribution Pattern

US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.

Other Recalls by Fresenius Kabi USA, LLC

View all recalls by Fresenius Kabi USA, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.