FDAHealthAugust 29, 2025
Baxter Healthcare Corporation — CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
⚠️ IV sets may leak.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 29, 2025
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.
What's affected?
- Product
- CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
- Lot code
- R25C03055
Additional details
UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 136512.
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