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.
Reported: December 10, 2025 Initiated: November 3, 2025 #Z-0586-2026
Product Description
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.
Reason for Recall
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 483 cases (12,075 eaches)
- Distribution
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Location
- North Andover, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 483 cases (12,075 eaches).
Why was this product recalled? ▼
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Critical. Recall number: Z-0586-2026.
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