Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
IVENIX INFUSION SYSTEM Recalled by Fresenius Kabi USA, LLC Due to Incorrect assembly of specific lot of LVP Primary...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.
Affected Products
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.
Quantity: 483 cases (12,075 eaches)
Why Was This Recalled?
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report