FDA Device recall Z-1291-2024
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
- FDA Device
- Class II
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class II recall of CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 by Baxter Healthcare, citing baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip cham….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1291-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-08 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Reason
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating from the drip chamber.
Identifiers
| code_info | UDI/DI 00085412565767, Lot Number R23A02062, exp. 1 Jan 2025 |
|---|
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-1291-2024%22
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