Home / Recalls / Fresenius Kabi USA, LLC / Z-1484-2024

Z-1484-2024 Class I Ongoing

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

FDA device recall Z-1484-2024 was initiated by Fresenius Kabi USA, LLC on March 7, 2024 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 17 units.

Recall Details

Product Type
Devices
Report Date
April 17, 2024
Initiation Date
March 7, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17 units

Product Description

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

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.

Distribution Pattern

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

Code Information

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

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-2223-2026 Class I — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. (May 6, 2026)
  • Z-2224-2026 Class I — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 (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-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)
  • D-0433-2026 Class II — 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in (March 11, 2026)
  • D-0424-2026 Class II — 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 25 (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-0426-2026 Class II — 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 (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)

FDA data resources