FDA-Device2018-08-29Class I
The Tri-Flo Subglottic Suction System
Vyaire Medical
Hazard
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.
Sold states
Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
Affected count
2150 Units Total
Manufactured in
26125 N Riverwoods Blvd, Mettawa, IL, United States
Products
The Tri-Flo Subglottic Suction System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2826-2018Don't want to check this manually?
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