medical Class I Updated 2018-08-29

Vyaire Medical recalls The Tri-Flo Subglottic Suction System

Recalled Product

The Tri-Flo Subglottic Suction System

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI
Lot/Code Info: Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
View official government recall

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