Drug recall
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
FDA recall event 65449 · Class I · Bryan Medical Inc
Key facts
| Event ID | 65449 |
|---|---|
| Recall numbers | Z-1667-2013 |
| Recalling firm | Bryan Medical Inc |
| Product type | Devices |
| Products | Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. |
| Initiation date | Apr 17, 2013 |
| Report date | Jul 17, 2013 |
| Termination date | Oct 29, 2013 |
| City | Cincinnati |
| State | OH |
| Country | United States |
| FEI number | 3005803389 |
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: