FDAFDA · Food and drugs·Recall number Z-0190-2026
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Published October 22, 2025 · Recall initiated: August 29, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
IV sets may leak.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- 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.
- Lot
- UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.