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Recall Observatory FDA recall evidence

Device product

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

Z-0197-2026

August 29, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 97604
Status
Ongoing
Classification
Class II
Quantity
15552
Official record key
device-enforcement:Z-0197-2026

Official wording

Reason: IV sets may leak.

Code information: UDI/DI 00085412048963, Lot numbers: R25C31024

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.