Recall
FDAHealthAugust 29, 2025

Baxter Healthcare Corporation — CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code

⚠️ 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 EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
Lot code
R25A21024

Additional details

UDI/DI 00085412049021, Lot numbers: R25A21024

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 16416.

View original FDA notice →

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