PlainRecalls
FDA Devices Moderate Class II Ongoing

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610

Reported: October 22, 2025 Initiated: August 29, 2025 #Z-0197-2026

Product Description

CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610

Reason for Recall

IV sets may leak.

Details

Units Affected
15552
Distribution
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.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled?
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610. Recalled by Baxter Healthcare Corporation. Units affected: 15552.
Why was this product recalled?
IV sets may leak.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 22, 2025. Severity: Moderate. Recall number: Z-0197-2026.