Device product
The Tri-Flo Subglottic Suction System
Z-2826-2018
Product summary
- Firm
- Vyaire Medical
- Event
- Event 80508
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2150 Units Total
- Official record key
device-enforcement:Z-2826-2018
Official wording
Reason: 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.
Code information: Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.
Distribution pattern: Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.
Derived failure modes
-
Foreign material or chemical contamination
foreign body