FDA Medical Device Recall

Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

KCER Release Date: September 17, 2024

To: KCER Distribution list- including ESRD Network EDs and QIDs

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

• 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: 3010538

What to Do

• Do not use affected product.

This recall is limited to a specific lot: 3010538. Other lots are not affected.

On August 2, 2024, Fresenius Kabi sent all affected customers an Urgent Voluntary Recall letter recommending the following actions:

• Stop using and distributing affected product immediately.

• Check inventory and quarantine affected product.

• Destroy or return affected product and request replacements.

• Contact Fresenius Kabi Customer Service at 855-354-6387, Prompt 1, if you intend to destroy recalled product or request replacements.

• Replace inventory with unaffected product.

• Make sure all potential users are aware of the notification.

• Complete the customer reply form included with the letter by fax or email, even if there is no affected product on hand.

Reason for Recall

Fresenius Kabi is recalling a certain lot of the Ivenix LVP Primary Administration Sets after identifying a manufacturing defect that may cause uncontrolled medication flow.

The use of affected product may cause serious adverse health consequences, including medication overdose and death.

There have been two reported injuries. There have been no reports of death.

Device Use

The Ivenix Large Volume Pump (LVP) is one of three primary components of the Ivenix Infusion System. It is a pump that uses air pressure to precisely control the flow of fluids to the patient. The system is used in hospitals and outpatient centers to carefully give fluids to patients, through different routes like IVs, in arteries, in the spine, or under the skin. It is intended for adults, pediatrics, and newborn babies.

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

Contact Information 

Customers in the U.S. with questions about this recall should contact Fresenius Kabi customer support at 1-855-351-6387 or ivenix_support@fresenius-kabi.com.

Additional FDA Resources 

• FDA’s Enforcement Report

• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?

• AccessGUDID database - Identify Your Medical Device

• Benefits of a UDI System

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.