Fresenius Kabi USA, LLC: Medical Device Recall in 2022 - (Recall #: Z-0002-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Product Classification:

Class I

Date Initiated: September 8, 2022

Date Posted: October 12, 2022

Recall Number: Z-0002-2023

Event ID: 90845

Reason for Recall:

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

Status: Terminated

Product Quantity: 4 instances

Code Information:

UDI-DI: 00811505030122 version 5.2.0

Distribution Pattern:

Domestic distribution to NJ and WI.

Voluntary or Mandated:

Voluntary: Firm initiated