FDAHealthJune 24, 2025
Fresenius Kabi USA, LLC — LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
⚠️ 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 Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
- Lot code
- FA24K25146
Additional details
Product Code: SET-0021-25. UDI-DI: 00811505030108. Lot Codes: FA24K25146, FA24K25153.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 35,925 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.