Reported Aug 6, 2025 · Ongoing
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code:…
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, Dual Y-Site (Qty 25)
- Product CodeSET-0032-25
- Lot codes and dates
- Product CodeSET-0032-25
- UDI-DI00811505030214
- Lot Codes
FA24J03137FA24J03145FA24J07013FA24J07021FA24J14019FA24J14027FA24J21246FA24J21253FA24J24141FA24J24166FA24J28027FA24J28035FA24K01154FA24K01162FA24K11039FA24K11047FA24K11161FA24K18034FA24K18042FA24K18059FA24K25229FA24L03133FA24L09221FA24L10203FA24L11201FA24L11219FA24L16010FA24L16028FA24L16036FA24L18180FA24L19139FA24L19147
- Amount recalled
- 348,150 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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