Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fresenius Kabi USA, LLC
- Reason for Recall:
- Emphasizing instructions for LVP duration programming located in the IFU.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Product Codes/Lot Numbers:
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1048-2026
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