Fresenius Kabi USA,Llc
Fresenius Kabi USA,Llc holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2018, with 24 FDA device recalls on record.
Top product codes for Fresenius Kabi USA,Llc
FDA recalls by Fresenius Kabi USA,Llc
10 most recent of 24- Z-2223-2026 — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Z-2224-2026 — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Z-1048-2026 — Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Z-0885-2026 — Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Z-0848-2026 — Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Z-0586-2026 — 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.
- Z-0378-2026 — Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Z-2232-2025 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
- Z-2235-2025 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- Z-2234-2025 — LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Fresenius Kabi USA,Llc
Data sourced from openFDA. This site is unofficial and independent of the FDA.