Recall
FDAHealthAugust 29, 2025

Baxter Healthcare Corporation — CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519

⚠️ 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, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
Lot code
R25C26116

Additional details

UDI/DI 00085412565682, Lot numbers: R25C26116

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 48096.

View original FDA notice →

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