LVP Primary Administration Sets recalled due to potential external cassette leaks
Fresenius Kabi USA recalls 348,150 LVP Primary Administration Sets nationwide due to potential for external cassette leaks that may affect medication delivery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA medical device recall for a risk-of-harm product (intravenous administration set) with potential for external cassette leaks. Although no illnesses or injuries have been reported and the hazard is theoretical, IV administration sets are critical for proper patient medication delivery, and external leaks could result in serious patient harm.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 348,150 LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Product Code SET-0032-25) due to a potential for external cassette leaks. The affected product has been distributed nationwide to states including California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, and Wisconsin.
The LVP Primary Administration Sets are used to deliver intravenous medications and fluids to patients. External cassette leaks on these sets could potentially result in improper medication delivery, loss of sterility, or other complications affecting patient care.
This is a Class II recall. Consumers and healthcare facilities that have received affected lots should stop using the recalled sets immediately. Affected lot codes range from FA24J03137 through FA24L19147. Healthcare providers should contact Fresenius Kabi USA, LLC for further instructions regarding returns or replacement products.
The recalled product
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- Manufacturer
- Fresenius Kabi USA, LLC
- Hazard
- external-leak
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: FA24J03137
- FA24J03145
- FA24J07013
- FA24J07021
- FA24J14019
- FA24J14027
- FA24J21246
- FA24J21253
- FA24J24141
- FA24J24166
- FA24J28027
- FA24J28035
- FA24K01154
- FA24K01162
- FA24K11039
- FA24K11047
- FA24K11161
- FA24K18034
- FA24K18042
- FA24K18059
Distribution
Distributed nationwide across the United States.
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