# FDA recall Z-0793-2020

> **Baxter Healthcare Corporation** · Class II · device recall initiated 2019-12-12.

## 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.

## Distribution

Worldwide distribution - US Nationwide distribution and countries of Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana and Barbados, Mexico, Canada, and New Zealand.

## Key facts

- **Recall number:** Z-0793-2020
- **Recalling firm:** Baxter Healthcare Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-12-12
- **Report date:** 2020-01-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Deerfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0793-2020

## Citation

> AI Analytics. FDA recall Z-0793-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0793-2020. Source: US FDA. Licensed CC0.

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