Fresenius Kabi USA, LLC: Medical Device Recall in 2024 - (Recall #: Z-1484-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.

Product Classification:

Class I

Date Initiated: March 7, 2024

Date Posted: April 17, 2024

Recall Number: Z-1484-2024

Event ID: 94228

Reason for Recall:

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

Status: Ongoing

Product Quantity: 17 units

Code Information:

Product LVP-SW-0004; UDI-DI 00811505030122.

Distribution Pattern:

US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.

Voluntary or Mandated:

Voluntary: Firm initiated