[pending] IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, D
Pending LLM rewrite. Source: FDA_DEVICE Z-0586-2026.
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
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
The recalled product
- Product
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump 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)
- Product Code: SET-0032-25
- UDI: 00811505030214
- Lot No. FA25B03126.
Distribution
Distributed nationwide across the United States.
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