This Early Alert communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending certain Ivenix large volume pump (LVP) Primary Administration sets be removed from where they are used or sold:

  • LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site
  • Product Code: SET-0032-01 (individual unit), SET-0032-25 (case)
  • Lot: FA25B03126
  • Unique Device Identifier: 00811505030214

What to Do

Check your inventory for affected stock and discontinue use and distribution immediately.

On October 30, Fresenius Kabi sent all affected customers a letter recommending the following actions:

  • Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.
  • Inform potential product users in your organization of this notification and replace with unaffected product.
  • Complete the attached Customer Reply Form and return it via the fax number or email address listed in the reply form. If your facility further distributes or transfers products to satellite sites or other locations, please inform all downstream customers about this recall.
    • Option A: If you no longer have any inventory of the affected product, please complete the response form and return it to Fresenius Kabi.
    • Option B: If you have affected product in your inventory, please either destroy it or return it. If you have questions or need to request replacement inventory, contact Fresenius Kabi Customer Service at 855-354-6387 (Prompt 1). If you choose to destroy the product, Fresenius Kabi will provide a Certificate of Destruction, which must be completed and returned.

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

Fresenius Kabi has identified a misassembly defect within a specific lot of the Ivenix LVP Primary Administration Set where the drip chamber and Luer Lock are in reversed positions, potentially leading to clinical complications.

An affected set has the Luer Lock connected proximally (upstream) in relation to the cassette and the drip chamber connected distally (downstream) in relation to the cassette. See Figure 1, Set Assembly, below.

A properly assembled set has the Drip Chamber connected proximally (upstream) in relation to the cassette, and the Luer Lock connected distally (downstream) in relation to the cassette. See Figure 1, Set Assembly, below.

Use of a misassembled set to administer therapy via the Ivenix LVP may lead to reverse flow, where negative pressure draws fluid from the patient connection (Luer Lock) and positive pressure forces fluid back toward the source container (drip chamber). The shortened downstream tubing (approximately 24 inches instead of approximately 72 inches) may also prevent proper connection to the patient access site unless extension tubing is used.

The degree of risk to the patient is influenced by factors such as the patient condition, flow rate, location of the Luer Lock connection, and level of oversight. Risks to patients include unexpected infusate delivery due to reverse flow, as well as delay in delivery of life-saving fluids, medications, and blood products. Harms may range from minor (self-limited blood loss in a stable adult) to catastrophic (exsanguination or hemodynamic compromise in neonates or other high-risk populations). Clinical outcomes can vary from asymptomatic to serious adverse events, especially in vulnerable populations such as neonates and hemodynamically unstable patients.

Note: Reverse flow does not occur if using the misassembled administration set to infuse via gravity.

As of October 30, 2025, Fresenius Kabi has reported no serious injuries or deaths associated with this issue.

Device Use

The Ivenix LVP is a large volume infusion pump designed to deliver fluids and medications from one of two inlet source containers to the patient through a single outlet. When loaded with an administration set, the LVP delivers infusion therapy to an individual patient.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi USA at Ivenix_support@fresenius-kabi.com or 1-855-354-6387.

Unique Device Identifier (UDI)  

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?  

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.