FDAHealthAugust 29, 2025
Baxter Healthcare Corporation — 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), P
⚠️ 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 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 2C8541
- Lot code
- R25A17123
Additional details
UDI/DI 00085412071107, Lot numbers: R25A17123, R25B20048, R25B21024, R25B24093, R25B26154, R25B27123, R25B27161, R25C04055, R25C05048, R25C05109, R25C06123, R25C08154, R25C10079, R25C11062, R25C18093, R25D12208, R25D21024.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1167120.
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