Fresenius Kabi USA, LLC: IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusi
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- 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.
- Reason / hazard
- Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- Recall initiated
- 2025-11-03
- Code info
- Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
- Product quantity
- 483 cases (12,075 eaches)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- North Andover
- State
- MA
- Country
- United States
- Event id
- 97941
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