Recall
FDAHealthAugust 29, 2025

Baxter Healthcare Corporation — CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

⚠️ 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, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425
Lot code
R25C27086

Additional details

UDI/DI 00085412071190, Lot numbers: R25C27086

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1440.

View original FDA notice →

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