Lower riskMedical device recall · FDA · Published April 22, 2022
Fresenius Kabi Ivenix Infusion System Software 5.0.0/1 Recall: Flow Rate Timing Risk
Fresenius Kabi recalls Ivenix Infusion System software versions 5.0.0 and 5.0.1 due to potential flow rate timing issues that could exceed 6 minutes in certain conditions. Affected units have specific software and part numbers.
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Take action
Contact the company
📍Recalling firmFresenius Kabi USA, LLC50 High St Ste 50 · North Andover, MA 01845-2620
✎ GovInfoNow plain-language explainer
Fresenius Kabi is recalling software versions 5.0.0 and 5.0.1 for their Ivenix Infusion System pumps. This software version may cause flow rates between 50-200 ml/hr to take longer than 6 minutes to start, which could lead to complications if air bubbles get trapped in the pump. Read more at govinfonow.com/recall/60775-fresenius-kabi-ivenix-infusion-system-software-5-0-0-1.
“Fresenius Kabi Ivenix Infusion System Software 5.0.0/1 Recall: Flow Rate Timing Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60775-fresenius-kabi-ivenix-infusion-system-software-5-0-0-1. Based on FDA recall #Z-2635-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2635-2023%22&limit=1).
The FDA announced on April 22, 2022, that Fresenius Kabi USA, LLC is recalling Ivenix Infusion System Large Volume Pump software versions 5.0.0 and 5.0.1 due to potential start-up time delays. The agency classified the recall as Class II.
How to tell if you have it
Brand: Fresenius Kabi
Product: Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software
Software versions: 5.0.0 and 5.0.1
Part Number: LVP-SW-0004
Units affected: 1344 pumps
The hazard
According to the FDA, the start-up time for flow rates greater than 50 ml/hr and less than 200 ml/hr may exceed the specified six minutes. This delay depends on air bubble entrapment within the Intermediate Pumping Chamber of the administration set.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has had 65 other recalls since September 27, 2012. Recent brand recalls include a Tyenne Injection recall on August 10, 2026, for glass particles, Morphine syringes with wrong labeling on August 4, 2026, and Xylocaine Injection with hair particulates on July 16, 2026. Other recent recalls of similar products include the Baxter Novum IQ Syringe Pump recall (August 11, 2026), the ICU Medical Plum Duo Infusion Pump recall (April 29, 2026), and the BD Alaris Pump Infusion Sets recall (August 19, 2026).
How to tell if you have this one
Check for software versions 5.0.0 or 5.0.1 labeled as LVP-SW-0004 on the Ivenix Infusion System (IIS) Large Volume Pump. These versions are used in hospitals and outpatient care settings for fluid administration.
Brand
Fresenius Kabi
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Look for software version numbers 5.0.0 or 5.0.1 on the Ivenix Infusion System pump.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NJ, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: New Jersey, Wisconsin.
Recall timeline
FDA published this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2635-2023 (April 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2635-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.