Device product
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Z-0191-2026
Product summary
- Event
- Event 97604
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1440
- Official record key
device-enforcement:Z-0191-2026
Official wording
Reason: IV sets may leak.
Code information: UDI/DI 00085412071190, Lot numbers: R25C27086
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.