Device product
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Z-0194-2026
Product summary
- Event
- Event 97604
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1167120
- Official record key
device-enforcement:Z-0194-2026
Official wording
Reason: IV sets may leak.
Code information: UDI/DI 00085412071107, Lot numbers: R25A17123, R25B20048, R25B21024, R25B24093, R25B26154, R25B27123, R25B27161, R25C04055, R25C05048, R25C05109, R25C06123, R25C08154, R25C10079, R25C11062, R25C18093, R25D12208, R25D21024.
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.