CLASS I Device recall · Reported 17 Jul 2013 · FDA Enforcement Report
Tracoe Mini Tube, for pediatric use recalled by Bryan Medical
Bryan Medical is recalling Tracoe Mini Tube, for pediatric use, distributed in Alabama, Kentucky. The recall was initiated on 17 Apr 2013 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1667-2013
- FDA event ID
- 65449
- Recalling firm
- Bryan Medical, Cincinnati, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Apr 2013
- FDA classified
- 8 Jul 2013
- Reported
- 17 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 17 Apr 2013 | Recall initiated by company | |
| 8 Jul 2013 | Classified by FDA | +82 days |
| 17 Jul 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Product as listed by the FDA
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Where it was distributed
Distributed in KY and AL.
Questions about this recall
Why was it recalled?
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Which lots are affected?
The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
Where was it sold?
Distributed in KY and AL.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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