Clearlink System Continu-Flo Administration Sets — Class II medical device recall Z-0793-2020
Ongoing recall by Baxter Healthcare Corporation, reported 2020-01-15, distributed nationwide. Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diamet
| Recall number | Z-0793-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2019-12-12 |
| Classified | 2020-01-09 |
| Reported by FDA | 2020-01-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BM, BS, CA, GY, KY, MX, NZ, TT |
| Quantity | 271,014,984 units |
| UPC / GTIN / UDI-DI | 00085412048970, 00085412048994, 00085412071107 |
Product
Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.
Reason for recall
Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector.
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-0793-2020. 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.