Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

LVP Primary Administration Set Recalled by Fresenius Kabi USA, LLC Due to A defect may cause an uncontrolled medication flow...

Date: August 1, 2024
Company: Fresenius Kabi USA, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.

Affected Products

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

Quantity: 180 cases/4,500 pieces

Why Was This Recalled?

A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

Where Was This Sold?

This product was distributed to 4 states: CO, ID, NJ, UT

Affected (4 states)Not affected

About Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report