Recall Announcement: Fresenius Withdraws Ivenix Infusion Pump Administration Sets

Recall Announcement: Fresenius Withdraws Ivenix Infusion Pump Administration Sets

Recall Announcement: Fresenius Withdraws Ivenix Infusion Pump Administration Sets

This recall entails withdrawing specific devices from usage or sale locations. This recall is noted by the FDA as the most severe type. Continued use of this device could result in serious injury or even fatality.

Products Involved

  • Product Names: Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
  • Unique Device Identifier (UDI)/Product Code: 20811505030058/SET-0013-25
  • Lot Number: 3010538

Recommended Actions

  • Refrain from using the impacted product.

This recall is restricted to lot number 3010538. Other lots remain unaffected.

On August 2, 2024, Fresenius Kabi issued an Urgent Voluntary Recall letter to all impacted customers advising the following measures:

  • Immediately cease use and distribution of the affected product.
  • Examine your inventory and segregate the affected product.
  • Dispose of or return the affected product and request replacements.
    • For product disposal or replacements, reach out to Fresenius Kabi Customer Service at 855-354-6387, Prompt 1.
  • Substitute the inventory with unaffected products.
  • Ensure all potential users are informed regarding this notification.
  • Complete and send back the customer reply form included in the letter via fax or email, even if no affected product is present.

Recall Justification

This recall was initiated by Fresenius Kabi due to a discovered manufacturing defect in the Ivenix LVP Primary Administration Sets that can lead to uncontrolled medication flow.

The utilization of the affected product can result in serious health repercussions, including medication overdoses and fatalities.

Two injuries have been recorded, although no deaths have been reported.

Device Purpose

The Ivenix Large Volume Pump (LVP) is a key component of the Ivenix Infusion System. It employs air pressure to accurately regulate the fluid flow to the patient. This system is utilized in hospitals and outpatient facilities to administer fluids to patients via various routes such as IVs, arterial lines, spinal injections, or subcutaneously. The pump is designed for adults, children, and newborns.

The Ivenix Large Volume Pump is exclusively compatible with certain sterile, single-use, disposable administration sets, which include the Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site.

Contact Details

For any inquiries regarding this recall, U.S. customers should contact Fresenius Kabi customer support at 1-855-351-6387 or via email at ivenix_support@fresenius-kabi.com.

FDA Additional Resources

Unique Device Identifier (UDI)

The UDI is critical in identifying individual medical devices sold in the United States, from manufacturing through distribution to patient application. This identifier enhances accurate reporting, evaluation, and examination of adverse event reports, facilitating quicker identification of devices and rectification of potential issues.

How to Report Issues?

Health care professionals and consumers can report any adverse reactions or quality issues encountered with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.