Recall Z-1667-2013 ยท BTO Tube, Tracheostomy (W/Wo Connector)
Bryan Medical Inc
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
| Date | Jul 8, 2013 (initiated Apr 17, 2013) |
| Status | Terminated |
| Reason | The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes. |
| Root cause | Labeling Change Control |
| Action | The consignees were contacted by telephone and asked to return the recalled product. |
| Quantity | 5 units |
| Distribution | Distributed in KY and AL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K893866 | HOOD PEDIATRIC TRACHEOSTOMY TUBE Hood Laboratories, Aug 7, 1989 |