Device product
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer Activated Valve, 19-inch (47 centimeters), Product Code 2H8603
Z-0200-2026
Product summary
- Event
- Event 97604
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 69936
- Official record key
device-enforcement:Z-0200-2026
Official wording
Reason: IV sets may leak.
Code information: UDI/DI 00085412046433, Lot numbers: R25C26154 and R25C27079
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.