Z-0197-2026 Class II Ongoing
FDA device recall Z-0197-2026 was initiated by Baxter Healthcare Corporation on Aug 29, 2025 and is designated Class II. Reason for recall: IV sets may leak. The recall status is ongoing. Affected quantity: 15552.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 22, 2025
- Initiation Date
- Aug 29, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15552
Product Description
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 44-inch (111 centimeters), Product code 2C8610
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 00085412048963, Lot numbers: R25C31024