FDAHealthJune 24, 2025
Fresenius Kabi USA, LLC — LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
⚠️ Potential for external cassette leaks
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 24, 2025
US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
What's affected?
- Product
- LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
- Lot code
- FA24K05023
Additional details
Product Code: SET-0014-20. UDI-DI: 00811505030030. Lot Codes: FA24K05023, FA24L02010, FA24L04198, FA24L04214.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,280 units.
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