FDA Device recall Z-1011-2025
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
- FDA Device
- Class II
- ongoing
- Published 2025-01-29
On 2025-01-29 the FDA classified a Class II recall of Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 by Baxter Healthcare, citing specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1011-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-20 |
| Published | 2025-01-29 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519
Reason
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable.
Identifiers
| code_info | UDI/DI 00085412486512, Lot Numbers: DR24B21017 (exp. 02/28/2026) |
|---|
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-1011-2025%22
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