Device product
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Z-2232-2025
Product summary
- Event
- Event 97165
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19,225 units
- Official record key
device-enforcement:Z-2232-2025
Official wording
Reason: Potential for external cassette leaks
Code information: Product Code: SET-0013-25. UDI-DI: 00811505030054. Lot Codes: FA24I26149, FA24I30133, FA24I30141, FA24J01131, FA24J01149.
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