CLEARLINK Non-DEHP Solution Set Luer Lock Adapter — Class II medical device recall Z-1291-2024
Ongoing recall by Baxter Healthcare Corporation, reported 2024-03-20, distributed nationwide. Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution s
| Recall number | Z-1291-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2024-02-08 |
| Classified | 2024-03-14 |
| Reported by FDA | 2024-03-20 |
| Distributed | Nationwide (US) |
| Quantity | 26,592 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00085412565767 |
| Lot numbers | R23A02062 |
| Expiration dates | 2025-01-01 |
Product
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1291-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.