FDAFDA · Food and drugs·Recall number Z-0002-2023
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Published October 12, 2022 · Recall initiated: September 8, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Domestic distribution to NJ and WI.
- Lot
- UDI-DI: 00811505030122 version 5.2.0
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.