Tracoe Mini 3.0mm Tube recall: Labeling Error
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Why was Tracoe Mini 3.0mm Tube recalled?
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
- Product
- Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
- Recalling firm
- Bryan Medical Inc
- Quantity
- 5 units
- Distribution
- Distributed in KY and AL.
- Recall date
- July 17, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)