Fresenius Kabi USA, LLC: Medical Device Recall in 2024 - (Recall #: Z-1282-2024)

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), LVP-SW-0004

Product Classification:

Class II

Date Initiated: September 16, 2022

Date Posted: March 20, 2024

Recall Number: Z-1282-2024

Event ID: 93958

Reason for Recall:

Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.

Status: Completed

Product Quantity: 3

Code Information:

UDI-DI 00811505030122 Software versions 5.0.1 and earlier.

Distribution Pattern:

US Nationwide distribution in the states of WI and NJ.

Voluntary or Mandated:

Voluntary: Firm initiated