FDAFDA · Food and drugs·Recall number Z-0193-2026
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 2C8537
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 00085412048970, Lot numbers: R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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