Fresenius Kabi LVP Primary Administration Sets recalled for potential external cassette leaks
Fresenius Kabi USA, LLC is recalling LVP Primary Administration Sets due to potential for external cassette leaks. The recall affects 35,925 units distributed nationwide.
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: FDA Class II recall of IV administration sets with potential for external cassette leaks. No reported injuries, illnesses, or deaths. This is a risk-of-harm product where injury has not yet been reported, fitting the High (Score 3) severity criterion.
Plain-English summary
Fresenius Kabi USA, LLC is recalling LVP Primary Administration Sets, Single Outlet Low Sorbing (Product Code SET-0021-25, Qty 25) due to potential for external cassette leaks. The recall affects 35,925 units distributed nationwide.
The affected products are identified by Lot Codes FA24K25146 and FA24K25153 (UDI-DI: 00811505030108). The FDA has classified this as a Class II recall.
The recalled product
- Product
- LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
- 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 (2)
- Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146
- FA24K25153.
Distribution
Distributed nationwide across the United States.
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