Medical device recalls Moderate risk

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

Recall date
June 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2234-2025
FDA classification
Class II
Brand / firm
Fresenius Kabi USA, LLC
Sold / distributed
US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Why it was recalled

Potential for external cassette leaks

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

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