Baxter CLEARLINK System — Class I medical device recall Z-1653-2022
Terminated recall by Baxter Healthcare Corporation, reported 2022-09-21, distributed nationwide. Firm noted an increase in customer reports of leaks.
| Recall number | Z-1653-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-08-09 |
| Classified | 2022-09-09 |
| Reported by FDA | 2022-09-21 |
| Terminated | 2024-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 511,728 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00085412656649 |
Product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Reason for recall
Firm noted an increase in customer reports of leaks.
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-1653-2022. 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.