Home / Recalls / Fresenius Kabi USA, LLC / Z-3153-2024

Z-3153-2024 Class I Ongoing

Recalled by Fresenius Kabi USA, LLC — North Andover, MA

FDA device recall Z-3153-2024 was initiated by Fresenius Kabi USA, LLC on August 30, 2024 and is designated Class I. Reason for recall: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death. The recall status is ongoing. Affected quantity: 17 units.

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
August 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

Product Description

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

Reason for Recall

The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

Distribution Pattern

US Nationwide.

Code Information

UDI-DI: 00811505030122; Software Version 5.9.1 and prior

Other recalls by Fresenius Kabi USA, LLC

  • D-0581-2026 Class III — Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka (May 14, 2026)
  • Z-2224-2026 Class I — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 (May 6, 2026)
  • Z-2223-2026 Class I — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. (May 6, 2026)
  • D-0435-2026 Class II — 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL free (March 11, 2026)
  • D-0425-2026 Class II — 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, (March 11, 2026)
  • D-0431-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a (March 11, 2026)
  • D-0437-2026 Class II — 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL f (March 11, 2026)
  • D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)
  • D-0432-2026 Class II — 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a (March 11, 2026)
  • D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)

FDA data resources