FDA Device recall Z-1667-2013
Tracoe Mini 3.0mm Tube, for pediatric use
- FDA Device
- Class I
- terminated
- Published 2013-07-17
On 2013-07-17 the FDA classified a Class I recall of Tracoe Mini 3.0mm Tube, for pediatric use by Bryan Medical, citing the pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1667-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-04-17 |
| Published | 2013-07-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bryan Medical |
| Distribution | AL, KY |
Product
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Reason
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Identifiers
| code_info | The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1667-2013%22
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