FDADecember 12, 2019device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

baxter healthcarebaxter

UPCs

000854120489940008541204897000085412071107

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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