Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1048-2026 — Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

U.S. FDA — Device Enforcement · United States · 2025-11-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1048-2026
Date of alert
2025-11-21
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Fresenius Kabi USA, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00811505030122
Reported risk: Emphasizing instructions for LVP duration programming located in the IFU.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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