Agency classClass IOur severity:Severe FDA (Devices)·Z-1869-2025·Announced 2025-06-18

Blood Products Administration Set Filter Mis-Assembly Recall

Fresenius Kabi USA is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets due to a mis-assembly error that may prevent the drip chamber filter from properly filtering large blood particulates.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. The mis-assembly defect directly affects blood product safety by preventing proper filtration of particulates that could harm patients receiving transfusions, constituting a structural or functional device defect with potential for serious injury.

Plain-English summary

Fresenius Kabi USA, LLC is recalling the IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set. The recall affects 14,280 units (724 cases) with Model No. SET-0014-20, UDI 20811505030034, and Lot No. FA24K05015.

The product is being recalled because of a mis-assembly error where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates. This defect could compromise the safety of blood transfusions by allowing unfiltered particles to reach patients.

The affected units were distributed across the following U.S. states: California, Colorado, Delaware, Georgia, Illinois, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, Nevada, Oklahoma, South Carolina, Texas, Virginia, Washington, and Wisconsin.

Patients and healthcare providers who have received or are using this product should contact Fresenius Kabi USA, LLC for instructions on appropriate action, including verification of their product lot numbers and proper handling or replacement of affected sets.

The recalled product

Product: IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
Manufacturer: Fresenius Kabi USA, LLC
Category: Medical Device — Blood Administration Set
Hazard: filter-malfunction
contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Model No. SET-0014-20
UDI 20811505030034
Lot No. FA24K05015.

Distribution

Distributed in 18 states:

Same manufacturer · Fresenius Kabi USA, LLC

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