On January 10, 2026, the FDA issued an update regarding Fresenius Kabi’s recall of specific Ivenix Large Volume Pump (LVP) Primary Administration Sets. This recall is categorized as the most serious type by the FDA due to the potential risk of serious injury or death. Healthcare providers, quality teams, and regulatory professionals must address this issue promptly to protect patient safety.
What Changed?
Fresenius Kabi identified a significant design flaw affecting certain administration sets for their Ivenix LVP. A misassembly issue has been detected within a particular lot (Lot: FA25B03126). This involves the reversed positioning of the drip chamber and the Luer Lock, leading to serious risks such as unexpected fluid flow and delayed delivery of life-critical substances.
The affected sets can cause reverse flow, where fluid is pulled from the patient and forced back toward the container. This issue is further complicated by shortened tubing, which may prevent proper connection without additional extension tubing.
Who Is Affected?
This recall primarily impacts healthcare providers who use the affected administration sets for delivering fluids, medications, or blood products via the Ivenix LVP system. Neonates, patients in critical condition, and individuals requiring hemodynamic stability are particularly vulnerable to the potential complications posed by these misassembled devices.
How to Identify the Affected Lot?
The affected product has the following identifiers:
- Product Code: SET-0032-01 (individual unit), SET-0032-25 (case)
- Lot Number: FA25B03126
- Unique Device Identifier (UDI): 00811505030214
If you have this product in inventory, discontinue its use and distribution immediately. Inspect all stock within your facility to ensure the affected lot is properly quarantined.
Steps to Take
Immediate Actions
Fresenius Kabi has provided the following guidance for customers:
- Stop using and distributing the affected sets immediately.
- Check your inventory for affected lots and quarantine any identified products.
- Inform all relevant personnel within your organization and downstream users.
Customers are asked to complete the Customer Reply Form included in the notification letter and return it to Fresenius Kabi via the provided contact information. You may destroy the product or return it to the manufacturer. If destruction is chosen, a Certificate of Destruction must be completed and submitted to Fresenius Kabi.
Replacement and Support
If replacement products are needed, affected customers are encouraged to reach out to Fresenius Kabi Customer Service at 1-855-354-6387 (Prompt 1) or Ivenix_support@fresenius-kabi.com for assistance.
Safety and Clinical Implications
The risks involved with using the misassembled sets include unintended infusate delivery, potential reverse flow, and delays in administering critical therapies. These risks may lead to a range of clinical outcomes, from minor complications to severe harm, especially in vulnerable patient populations such as neonates and critically ill individuals. Ensuring proper assembly and adherence to safety protocols can mitigate these risks.
Reporting Adverse Events
Healthcare professionals and consumers who experience adverse reactions or identify quality issues with the affected devices are encouraged to report them to the FDA MedWatch program. Accurate reporting helps improve device safety and enables quicker action to address medical device concerns.
Conclusion
Fresenius Kabi’s recall of specific Ivenix LVP Primary Administration Sets highlights the importance of addressing potential misassembly issues promptly. Healthcare providers must discontinue using affected products, check inventories, and inform all relevant parties. Adopting these measures will ensure patient safety and compliance with regulatory standards.
Disclaimer
This article is for informational purposes only and is not intended as legal or professional advice. Always consult regulatory guidelines or legal counsel for compliance matters.
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/infusion-pump-recall-fresenius-kabi-removes-ivenix-large-volume-pumps