Drug recall
The Tri-Flo Subglottic Suction System
FDA recall event 80508 · Class I · Vyaire Medical
Key facts
| Event ID | 80508 |
|---|---|
| Recall numbers | Z-2826-2018 |
| Recalling firm | Vyaire Medical |
| Product type | Devices |
| Products | The Tri-Flo Subglottic Suction System |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 20, 2018 |
| Report date | Aug 29, 2018 |
| Termination date | Jul 28, 2020 |
| City | Mettawa |
| State | IL |
| Country | United States |
| FEI number | 3013421741 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: