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

Recall Z-0002-2023 — Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

U.S. FDA — Device Enforcement · United States · 2022-09-08 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0002-2023
Date of alert
2022-09-08
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Fresenius Kabi USA, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00811505030122
Reported risk: The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.