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

IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set. — recall Z-0586-2026

U.S. FDA — Device Enforcement · United States · 2025-11-03 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0586-2026
Date of alert
2025-11-03
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)
00811505030214
Reported risk: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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