FDA Device recall Z-0190-2026
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419 by Baxter Healthcare, citing IV sets may leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0190-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-29 |
| Published | 2025-10-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419
Reason
IV sets may leak.
Identifiers
| code_info | UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0190-2026%22
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