FDA Device recall Z-0549-2024
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
- FDA Device
- Class I
- ongoing
- Published 2023-12-27
On 2023-12-27 the FDA classified a Class I recall of Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 by Fresenius Kabi Usa, citing the device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Dependi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0549-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-29 |
| Published | 2023-12-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CA, CO, NJ, UT, WI |
Product
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Reason
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
Identifiers
| code_info | UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212…UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212201118 2212201115 2212201113 2212201111 2212201100 2212201095 2212201093 2212201088 2212201076 2212201074 2212201061 2212201059 2212201046 2212201029 2212201024 2212201003 2212201002 2212200993 2212200990 2212200987 2212200986 2212200982 2212200978 2212200958 2212200952 2212200945 2212200938 2212200929 2212200914 2205900177 2205900176 2205900170 2205900167 2205900158 2205900152 2205900150 2205900143 2205900133 2205900132 2205900128 2205900126 2205900125 2205900113 2205900112 2205900110 2205900109 2205900108 2205900107 2205900106 2205900098 2205900096 2205900094 2205900091 2205900090 2205900074 2205900072 2205900071 2205900067 2205900062 2205900061 2201811620 2201811615 2201811614 2201811605 2118200011 2201811603 2201811600 2201811598 2201811597 2201811596 2201811594 2201811590 2201811585 2201811584 2201811582 2201811579 2201811577 2201811568 2201811567 2201811561 22018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0549-2024%22
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