Device product
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micron Filter, CLEARLINK Luer Activated Valve, 10 drops/mL, 107-inch (2.7 meters), Product Code 2R8858
Z-0203-2026
Product summary
- Event
- Event 97604
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27072
- Official record key
device-enforcement:Z-0203-2026
Official wording
Reason: IV sets may leak.
Code information: UDI/DI 00085412565774, Lot numbers: R25A13024
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.