FDA Device recall Z-0378-2026
Ivenix Infusion System (IIS), Large Volume Pump
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Ivenix Infusion System (IIS), Large Volume Pump by Fresenius Kabi Usa, citing potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0378-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-03 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Identifiers
| code_info | Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443. |
|---|
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-0378-2026%22
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