Device product
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Z-2233-2025
Product summary
- Event
- Event 97165
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,280 units
- Official record key
device-enforcement:Z-2233-2025
Official wording
Reason: Potential for external cassette leaks
Code information: Product Code: SET-0014-20. UDI-DI: 00811505030030. Lot Codes: FA24K05023, FA24L02010, FA24L04198, FA24L04214.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for external cassette leaks