Company: Fresenius Kabi USA, LLC
Date of Enforcement Report: 2/04/2025
Class I
PRODUCT
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.
Recall Number:
Z-1019-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Fresenius Kabi USA, LLC
VOLUME OF PRODUCT IN COMMERCE:
23 systems
DISTRIBUTION:
US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
