Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
This recall has been terminated (originally issued July 8, 2013).
- Company
- Bryan Medical Inc
- Recall Initiated
- April 17, 2013
- Posted
- July 8, 2013
- Terminated
- October 29, 2013
- Recall Number
- Z-1667-2013
- Quantity
- 5 units
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Distribution
Distributed in KY and AL.
Lot / Code Info
The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
Root Cause
Labeling Change Control
Action Taken
The consignees were contacted by telephone and asked to return the recalled product.
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