Fresenius Kabi IV Administration Sets Recalled for Potential External Cassette Leaks
Fresenius Kabi USA, LLC is recalling 19,225 units of its LVP Primary Administration Sets due to potential external cassette leaks. Affected lot codes have been distributed across multiple U.S. states.
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 FDA Class II recall of an intravenous administration device qualifies as a risk-of-harm product. Although no adverse events or injuries have been reported, potential external cassette leaks could impact medication delivery. Per the severity rubric, risk-of-harm products without reported injury are scored as High (3).
Plain-English summary
Fresenius Kabi USA, LLC has recalled its LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Product Code: SET-0013-25) due to a potential for external cassette leaks. Approximately 19,225 units have been identified as affected.
The recalled product was distributed to healthcare facilities in the following states: 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 affected lot codes are: FA24I26149, FA24I30133, FA24I30141, FA24J01131, and FA24J01149. The product is identified by product code SET-0013-25 and UDI-DI: 00811505030054.
External cassette leaks could disrupt the delivery of intravenous therapy. Healthcare facilities with affected lot codes in their inventory should review their supply for this product.
The recalled product
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
- 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 (5)
- Product Code: SET-0013-25. UDI-DI: 00811505030054. Lot Codes: FA24I26149
- FA24I30133
- FA24I30141
- FA24J01131
- FA24J01149.
Distribution
Distributed nationwide across the United States.
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