Recall Z-2235-2025— Fresenius Kabi USA, LLC

Name: FDA recall Z-2235-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-24

Class II · Ongoing

Class II FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2025-06-24. It names one FDA 510(k) clearance: K183311. Product: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.. Reason: Potential for external cassette leaks.

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-06-24
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Reason for recall

Potential for external cassette leaks

Data sourced from openFDA. This site is unofficial and independent of the FDA.