Z-0793-2020 Class II Ongoing
FDA device recall Z-0793-2020 was initiated by Baxter Healthcare Corporation on Dec 12, 2019 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 271,014,984 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 15, 2020
- Initiation Date
- Dec 12, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 271,014,984 units
Product Description
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 Pattern
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.
Code Information
Product Codes: 2C8519, UDI 00085412048994; 2C8537, UDI 00085412048970; and 2C8541, UDI 00085412071107 All Lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0793-2020
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026