Recall Z-2826-2018— Vyaire Medical
Class I · Terminated
Class I FDA medical device recall by Vyaire Medical, initiated 2018-06-20, terminated 2020-07-28. FDA's recall record names no specific 510(k) clearance for this event. Product: The Tri-Flo Subglottic Suction System. 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..
- Recalling firm
- Vyaire Medical
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2018-06-20
- Terminated
- 2020-07-28
- Firm location
- Mettawa, IL, United States
Product description
The Tri-Flo Subglottic Suction System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.