CLASS I ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report
Ivenix Infusion System, Lvp Primary Administration Set recalled
Fresenius Kabi USA is recalling Ivenix Infusion System, Lvp Primary Administration Set, Dual-Inlet, Low-Sorbing, distributed nationwide in the US. The recall was initiated on 3 Nov 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0586-2026
- FDA event ID
- 97941
- Recalling firm
- Fresenius Kabi USA, North Andover, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 3 Nov 2025
- FDA classified
- 3 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 3 Nov 2025 | Recall initiated by company | |
| 3 Dec 2025 | Classified by FDA | +30 days |
| 10 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
Nationwide IllinoisMarylandMichiganOklahomaSouth CarolinaTexasVirginiaWisconsin
Questions about this recall
Why was it recalled?
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Which lots are affected?
Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.
Where was it sold?
US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fresenius Kabi USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tyenne (tocilizumab-aazg) Injection, 400 mg/ (20 mg/mL) vial recalledTyenne | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Glycopyrrolate Injection, USP, 1 mg per (0.2 mg per mL) recalledGlycopyrrolate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
Other Infusion Pumps recalls
All 546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical | ICU Medical | Other | Nationwide |
| Device | CLASS II | Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled | Boston Scientific | Packaging Defects | Nationwide |