PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: October 22, 2025 Initiated: August 29, 2025 #Z-0194-2026

Product Description

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

Reason for Recall

IV sets may leak.

Details

Units Affected
1167120
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 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. Recalled by Baxter Healthcare Corporation. Units affected: 1167120.
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-0194-2026.