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 LVP Blood Products Administration Set Recalled by Fresenius Kabi USA, LLC Due to Mis-assembly error of Blood Products Administrations Sets where...
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 Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Quantity: 14,280 units (724 cases)
Why Was This Recalled?
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Where Was This Sold?
This product was distributed to 18 states: CA, CO, DE, GA, IL, MD, MI, MN, MS, NV, NJ, NC, OK, SC, TX, VA, WA, WI
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