🔍 RecallPedia

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Class I - Dangerous
🏥 Medical Devices Recalled: September 8, 2022 Fresenius Kabi USA Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00811505030122 version 5.2.0
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

Product Codes/Lot Numbers:

UDI-DI: 00811505030122 version 5.2.0

Distribution:

Distributed in: NJ, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0002-2023

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