[pending] IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh
Pending LLM rewrite. Source: FDA_DEVICE Z-1869-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
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 — Devices
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:
- CA
- CO
- DE
- GA
- IL
- MD
- MI
- MN
- MS
- NC
- NJ
- NV
- OK
- SC
- TX
- VA
- WA
- WI
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