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Baxter Healthcare Corporation: CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/

Medical DevicesSource: FDA (device) · Date: 2025-10-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Baxter Healthcare Corporation
Product
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 2C8537
Reason / hazard
IV sets may leak.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-08-29
Code info
UDI/DI 00085412048970, Lot numbers: R25A13055, R25B24024, R25B25154, R25C05017, R25C13147, R25C18017, R25C18024, R25C25116, R25C26093, R25C31079, R25D03055, R25D12123, R25D19024
Product quantity
958351
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
97604
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