Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
FDA device recall Z-1667-2013 · posted 2013-07-08 · Terminated
Recall details
- Recalling firm
- Bryan Medical Inc
- Reason for recall
- The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
- Action taken
- The consignees were contacted by telephone and asked to return the recalled product.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- BTO
- Quantity affected
- 5 units
- Distribution
- Distributed in KY and AL.
- Date initiated
- 2013-04-17
- Date posted
- 2013-07-08
- Date terminated
- 2013-10-29
- Location
- Cincinnati, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOOD PEDIATRIC TRACHEOSTOMY TUBE (K893866) | Hood Laboratories | 1989-08-07 |