Z-0190-2026 Class II Ongoing
FDA device recall Z-0190-2026 was initiated by Baxter Healthcare Corporation on August 29, 2025 and is designated Class II. Reason for recall: IV sets may leak. The recall status is ongoing. Affected quantity: 136512.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- August 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136512
Product Description
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Reason for Recall
IV sets may leak.
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.
Code Information
UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086