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 5.0.1 and earlier.
- 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 correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
- 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 5.0.1 and earlier.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1282-2024
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