Baxter Healthcare Corporation: Medical Device Recall in 2020 - (Recall #: Z-0793-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 12, 2019

Date Posted: January 15, 2020

Recall Number: Z-0793-2020

Event ID: 84511

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.

Status: Ongoing

Product Quantity: 271,014,984 units

Code Information:

Product Codes: 2C8519, UDI 00085412048994; 2C8537, UDI 00085412048970; and 2C8541, UDI 00085412071107 All Lots

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.

Voluntary or Mandated:

Voluntary: Firm initiated