The FDA has issued an Early Alert regarding a potential high-risk issue with certain Fresenius Kabi Ivenix Large Volume Pump (LVP) Primary Administration sets. This communication highlights a misassembly defect that could significantly impact patient safety during infusion therapy. Healthcare professionals, clinical teams, and regulatory specialists should take immediate note and review affected inventory to prevent possible harm.
What changed?
Fresenius Kabi discovered a misassembly defect in specific product lots of the LVP Primary Administration sets (Product Code: SET-0032-01 and SET-0032-25, Lot: FA25B03126). The drip chamber and Luer Lock are reversed, causing improper connections that may lead to reverse flow during infusion. This defect poses significant risks depending on patient conditions, flow rate settings, and the site of administration.
Who is affected?
This issue could affect healthcare facilities and professionals using Ivenix LVP Primary Administration sets to deliver fluids, medications, or blood products. Vulnerable patient populations, particularly neonates and hemodynamically unstable individuals, are at elevated risk of experiencing adverse outcomes from reverse flow, sudden infusate delivery, or delays in therapy.
Understanding the risk
Device Misassembly
An affected administration set has the Luer Lock positioned proximally (upstream) near the cassette and the drip chamber located distally (downstream). This is an inversion from the proper assembly where the drip chamber is connected proximally and the Luer Lock distally. These reversed components introduce negative pressure, drawing fluids out of the patient connection and cycling them back toward the source container.
Clinical Implications
Risk to patients ranges from minor and self-limited events, such as blood loss in a stable adult, to catastrophic consequences like extensive blood loss in neonates or critical delays in life-saving therapy. Reverse flow may also necessitate secondary interventions and additional oversight, increasing the workload for already strained clinical teams.
Current Reports
As of October 30, 2025, Fresenius Kabi has not reported any serious injuries or deaths linked to this issue. While encouraging, healthcare professionals must remain proactive by discontinuing the use of affected products immediately.
Recommended actions
Fresenius Kabi provided clear guidance for affected facilities:
- Stop using and distributing any administration sets from Lot FA25B03126. Quarantine all inventory onsite.
- Inform clinicians, pharmacists, and related personnel of the recall and risks involved.
- Replace misassembled products with unaffected stock immediately.
- Complete and submit the Customer Reply Form as instructed, confirming whether inventory includes affected products.
Facilities should choose between destruction or return of the defective devices. Fresenius Kabi will provide a Certificate of Destruction when applicable. For replacement inventory or additional assistance, contact Fresenius Kabi Customer Service at 1-855-354-6387 (Prompt 1).
How to report adverse events
Both healthcare professionals and consumers can report quality concerns or adverse reactions linked to these devices through MedWatch, the FDA’s reporting system. Reports can help accelerate solutions and improve public safety.
Conclusion
Healthcare providers must act swiftly to address this recall and ensure proper infusion practices. Preventing exposure to misassembled sets is crucial, particularly for high-risk patients relying on accurate and timely therapy delivery.
Disclaimer
This article is designed to provide regulatory information to healthcare professionals and stakeholders. It is not intended as legal or clinical advice and should not substitute thorough review of FDA resources or manufacturer notices.
Mandatory FDA Line
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-large-volume-pump-primary-administration-set-reverse-flow-issue-fresenius-kabi