Reported Oct 12, 2022 · Terminated

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Fresenius Kabi USA, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Kabi USA, LLC · 50 High St Ste 50 · North Andover, MA · 01845-2620

Is this the product you have?

  • Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Lot codes and dates
  • UDI-DI00811505030122 version 5.2.0
Amount recalled
4 instances

Where it was sold

Why it was recalled

Stop using this product now

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 10, 2024 · Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.