Device product
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Z-0190-2026
Product summary
- Event
- Event 97604
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 136512
- Official record key
device-enforcement:Z-0190-2026
Official wording
Reason: IV sets may leak.
Code information: UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086
Distribution pattern: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Derived failure modes
-
Unknown
IV sets may leak.