FDA Device recall Z-0763-2025
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- FDA Device
- Class I
- ongoing
- Published 2025-01-15
On 2025-01-15 the FDA classified a Class I recall of Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 by Fresenius Kabi Usa, citing potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0763-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-12-06 |
| Published | 2025-01-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | ID, MN, NV, TX, VA, WI |
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Identifiers
| code_info | Model Number: LVP-0004, UDI Number: 00811505030320. Serial Numbers: 9233532106, 9233421830, 9233421828, 9233532158,…Model Number: LVP-0004, UDI Number: 00811505030320. Serial Numbers: 9233532106, 9233421830, 9233421828, 9233532158, 9233522076, 9233522041, 9233421833, 9233421829, 9233421808, 9233421654, 9233421626, 9233421621, 9233321340, 2215401517, 2215401545, 9233421789, 9233421809, 9233532167, 9233532100, 9233522070, 9233421825, 9233421824, 9233421794, 9233421783, 9233421781, 9233421771, 9233421768, 9233421756, 9233421736, 9233421713, 9233421702, 9233421617, 9233421611, 9233391513, 9233391491, 9233532098, 9233421822, 9233421797, 9233421678, 9233421666, 9233421601, 9233532114, 9233421792, 9233421766, 9233421687, 2215401372, 9233522040, 9233522037, 9233421764, 9233421752, 9233421665, 9232490602, 9233522062, 9233421817, 9233421832, 9233522094, 9233421805, 9233421740, 9233532161, 9233532111, 9233522061, 9233421836, 2212200949, 2212200956, 2212200959, 2212200960, 2212200964, 2212200965, 2212200983, 2212200999, 2212201000, 2212201001, 2212201006, 2212201008, 2212201009, 2212201011, 2212201017, 22122 |
|---|
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-0763-2025%22
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