Drug recall
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in…
FDA recall event 82387 · Class II · Smiths Medical ASD Inc.
Key facts
| Event ID | 82387 |
|---|---|
| Recall numbers | Z-1732-2019 |
| Recalling firm | Smiths Medical ASD Inc. |
| Product type | Devices |
| Products | Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Packaged with an incorrect size inner cannula. |
| Initiation date | Feb 11, 2019 |
| Report date | Jun 12, 2019 |
| Termination date | Nov 2, 2020 |
| 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: