Recall database

Fresenius Kabi USA, LLC recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 13–15 of 15 recalls

Class IOngoingZ-1869-2025

Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set

Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.

Fresenius Kabi USA, LL…MAJun 18, 2025

Class IOngoingZ-1019-2025

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)

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.…

Fresenius Kabi USA, LL…MAFeb 12, 2025

Class IOngoingZ-0763-2025

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

Fresenius Kabi USA, LL…MAJan 15, 2025