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Recall Observatory FDA recall evidence

Device product

CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

Z-0191-2026

August 29, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 97604
Status
Ongoing
Classification
Class II
Quantity
1440
Official record key
device-enforcement:Z-0191-2026

Official wording

Reason: IV sets may leak.

Code information: UDI/DI 00085412071190, Lot numbers: R25C27086

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.