FDA Device recall Z-0194-2026
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops…
- FDA Device
- Class II
- ongoing
- Published 2025-10-22
On 2025-10-22 the FDA classified a Class II recall of CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops… by Baxter Healthcare, citing IV sets may leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0194-2026 |
| 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 CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractable Collar, 10 drops/mL, 120-inch (3.0 meters), Product Code 2C8541
Reason
IV sets may leak.
Identifiers
| code_info | UDI/DI 00085412071107, Lot numbers: R25A17123, R25B20048, R25B21024, R25B24093, R25B26154, R25B27123, R25B27161, R25C0…UDI/DI 00085412071107, Lot numbers: R25A17123, R25B20048, R25B21024, R25B24093, R25B26154, R25B27123, R25B27161, R25C04055, R25C05048, R25C05109, R25C06123, R25C08154, R25C10079, R25C11062, R25C18093, R25D12208, R25D21024. |
|---|
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-0194-2026%22
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