Tracoe Mini 3.0mm Tube, for pediatric use recallZ-1667-2013 · Bryan Medical Inc · initiated Apr 17, 2013
Class I Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bryan Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
FDA root cause category: Labeling Change Control
What the company is doing
The consignees were contacted by telephone and asked to return the recalled product.
Recall details
- Recall number
- Z-1667-2013
- Recall class
- Class I (most serious)
- Status
- Terminated
- Initiated by the company
- Apr 17, 2013
- Posted by the FDA
- Jul 8, 2013
- Recalling firm
- Bryan Medical Inc
- Quantity
- 5 units
- Product code
- BTO
- FDA submissions
- K893866
- Distribution
- Distributed in KY and AL.
Product description
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Code information (models, lots, serial numbers)
The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
Other devices under the same FDA submission
2 devices cleared under K893866 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRACOE mini REF 350-4.0Tracoe medical GmbH · Tube, tracheostomy (w/wo connector)1 report
- TRACOE mini REF 355-3.0Tracoe medical GmbH · Tube, tracheostomy (w/wo connector)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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