Vyaire Medical recalls The Tri-Flo Subglottic Suction System

Recall date

June 20, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2826-2018

FDA classification

Class I

Brand / firm

Vyaire Medical

Sold / distributed

Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.

Why it was recalled

Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

The Tri-Flo Subglottic Suction System