FDA Device recall Z-2224-2026
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- FDA Device
- Class I
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class I recall of Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 by Fresenius Kabi Usa, citing fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or re….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2224-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-06 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CA, CO, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI |
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Identifiers
| code_info | Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2224-2026%22
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