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
Product summary
- 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
particulates
-
Manufacturing or process control
assembly error