FDAFDA · Food and drugs·Recall number Z-1484-2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Published April 17, 2024 · Recall initiated: March 7, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- Lot
- Product LVP-SW-0004; UDI-DI 00811505030122.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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