The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning Tri-Flo Subglottic Suction System [Part number: CM28010; Lot/Serial Numbers: 0001158835, 0001158836, 0001158837, 0001185564, 0001194114, 0004008255, 0004008256], manufactured by Vyaire Medical.
The manufacturer has discovered potential patient safety risk associated with the use of 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.
For details, please refer to the following FDA website:
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=80508
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 29 August 2018