Z-0199-2026 Class II Ongoing
FDA device recall Z-0199-2026 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: 16416.
Recall details
- Product Type
- Devices
- Report Date
- Oct 22, 2025
- Initiation Date
- Aug 29, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16416
Product description
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable Collar, 7.9-inch (20 centimeters), Product Code 2C8634
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 00085412049021, Lot numbers: R25A21024
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0199-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026