Home / Recalls / Medical Devices
Vyaire Medical recalls The Tri-Flo Subglottic Suction System
Recalled August 29, 2018 · FDA recall Z-2826-2018 · 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. · FDA Class I
Units
2150 Units Total
Sold at
Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
Description
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.
Product
The Tri-Flo Subglottic Suction System
Manufacturer(s)
Vyaire Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →