Drug recall
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
FDA recall event 80092 · Class II · Smiths Medical ASD Inc.
Key facts
| Event ID | 80092 |
|---|---|
| Recall numbers | Z-2114-2018 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Devices |
| Products | Bivona¿ Tracheostomy Tube Tracheostomy Tubes |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile. |
| Initiation date | Apr 2, 2018 |
| Report date | Jun 13, 2018 |
| Termination date | Nov 14, 2018 |
| City | Minneapolis |
| State | MN |
| Country | United States |
| FEI number | 3012307300 |
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: