Z-0201-2026 Class II Ongoing
FDA device recall Z-0201-2026 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: 48096.
Recall details
- Product Type
- Devices
- Report Date
- Oct 22, 2025
- Initiation Date
- Aug 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48096
Product description
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 meters). Non-DEHP, Product Code 2R8519
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 00085412565682, Lot numbers: R25C26116
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0201-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026