Ivenix Primary Administration Infusion Pump Recalled Due to Uncontrolled Medication Flow

The manufacturer is instructing customers with recalled infusion pump systems to immediately destroy or quarantine the impacted products to prevent overdose injuries and deaths.

Federal health officials have announced a recall of certain infusion systems, after the manufacturer identified a defect that may allow too much medication to be delivered, which may result in a serious overdose injury or death.

The U.S. Food and Drug Administration (FDA) announced the Fresenius Kabi Ivenix infusion pump recall on September 16, 2024, warning healthcare professionals to immediately stop using recalled models after receiving reports of at least two injuries linked to the manufacturing defect.

The Ivenix Large Volume Pump (LVP) is one of three components of the Ivenix Infusion System, which is a medical device used in hospitals and outpatient care centers to administer precisely controlled fluids to a patient using air pressure.

Fluids can be administered through various routes, such as intravenously (IV), into arteries, into the spine or under the skin. The pumps can administer medications such as antibiotics, insulin, hormones, chemotherapy drugs and pain relievers.

Fresenius Kabi first notified healthcare providers about the potential manufacturing defect in an Urgent Voluntary Recall letter issued on August 2, 2024, advising all customers to immediately stop using and distributing the product.

According to the recall notice, a certain lot of the Ivenix LVP Primary Administration Sets may have been manufactured out of specification, and could increase the risk of uncontrolled medication flow that could lead to accidental overdosing of patients.

The recall includes Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, and Y-Site (Qty 25) with Unique Device Identifier (UDI) /Product Code: 20811505030058/SET-0013-25 that are marked with Lot number 3010538.

Following the manufacturer’s notice, the FDA categorized the action as a Class I recall, indicating it is the most serious of its kind, and that there is a reasonable probability that the use of the product could cause serious injury or death.

Customers are being instructed to check their inventory, and to destroy or return affected products and request replacements. Customers are urged to complete the customer reply form included with the letter, even if their product is not affected.

Individuals with additional questions or concerns regarding the recall or products impacted are encouraged to contact Fresenius Kabi customer support at 855-354-6387 or email ivenix_support@fresenius-kabi.com.