Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Class I - DangerousWhat Should You Do?
- Check if you have this product: (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
- 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:
- Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
- 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), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Product Codes/Lot Numbers:
(UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2635-2023
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