Device product
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Z-1667-2013
Product summary
- Event
- Event 65449
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1667-2013
Official wording
Reason: The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Code information: The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
Distribution pattern: Distributed in KY and AL.
Derived failure modes
-
Labeling or packaging
mislabeled