Reported Aug 6, 2025 · Ongoing

LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

Fresenius Kabi USA, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Fresenius Kabi USA, LLC · 50 High St Ste 50 · North Andover, MA · 01845-2620

Is this the product you have?

  • LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20)
  • Product CodeSET-0014-20
Lot codes and dates
  • Product CodeSET-0014-20
  • UDI-DI00811505030030
  • Lot Codes
    • FA24K05023
    • FA24L02010
    • FA24L04198
    • FA24L04214
Amount recalled
14,280 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

Potential for external cassette leaks

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.