FDA Device recall Z-1019-2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
- FDA Device
- Class I
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class I recall of Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 by Fresenius Kabi Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1019-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-10 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI |
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.
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.
Identifiers
| code_info | UDI-DI: 00811505030122. Software 5.9.2 and prior |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1019-2025%22
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