# FDA recall Z-0191-2026

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2025-08-29.

## Product

CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

## Reason for recall

IV sets may leak.

## Distribution

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.

## Key facts

- **Recall number:** Z-0191-2026
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-29
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0191-2026

## Citation

> AI Analytics. FDA recall Z-0191-2026. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0191-2026. Source: US FDA. Licensed CC0.

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