LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
- 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:
- Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Product Codes/Lot Numbers:
UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1283-2024
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