Z-0192-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- August 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 473040
Product Description
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519
Reason for Recall
IV sets may leak.
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.
Code Information
UDI/DI 00085412048994, Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, and R25C29185