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Recall Observatory FDA recall evidence

Device product

IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.

Z-1869-2025

May 12, 2025

Class I

Product summary

Firm
Fresenius Kabi USA, LLC
Event
Event 96880
Status
Ongoing
Classification
Class I
Quantity
14,280 units (724 cases)
Official record key
device-enforcement:Z-1869-2025

Official wording

Reason: 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.

Code information: Model No. SET-0014-20; UDI 20811505030034; Lot No. FA24K05015.

Distribution pattern: US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulates
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    assembly error