Reported Aug 6, 2025 · Ongoing
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
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 Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
- Product CodeSET-0013-25
- Lot codes and dates
- Product CodeSET-0013-25
- UDI-DI00811505030054
- Lot Codes
FA24I26149FA24I30133FA24I30141FA24J01131FA24J01149
- Amount recalled
- 19,225 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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