Skip to content
Recall Observatory FDA recall evidence

Device product

CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extension Set with two CLEARLINK Luer Activated Valve, Pfoduct code 2C6255

Z-0189-2026

August 29, 2025

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 97604
Status
Ongoing
Classification
Class II
Quantity
49200
Official record key
device-enforcement:Z-0189-2026

Official wording

Reason: IV sets may leak.

Code information: UDI/DI 00085412046310, Lot numbers: R25C26161 and R25D01031

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.