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Recall Observatory FDA recall evidence

Device 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

Z-0201-2026

August 29, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 97604
Status
Ongoing
Classification
Class II
Quantity
48096
Official record key
device-enforcement:Z-0201-2026

Official wording

Reason: IV sets may leak.

Code information: UDI/DI 00085412565682, Lot numbers: R25C26116

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    IV sets may leak.