Z-1667-2013Class I

Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access

Name: Z-1667-2013 Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access
Creator: Bryan Medical Inc
Published: 2013-04-17
License: https://open.fda.gov/license/

Bryan Medical Inc / initiated 2013-04-17 / Terminated / root cause: labeling and UDI

FDA source

Bryan Medical Inc began a recall of Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access on 2013-04-17. FDA classified it as Class I and gives the reason as "The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1667-2013
Classification: Class I
Status: Terminated
Initiated: 2013-04-17
Posted: 2013-07-08
Terminated: 2013-10-29
Recalling firm: Bryan Medical Inc
Product: Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: The consignees were contacted by telephone and asked to return the recalled product.
Quantity in commerce: 5 units
Distribution: Distributed in KY and AL.
Product codes and lots: The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1667-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1667-2013	Class I	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-08

Product code BTO

K893866Class IIHood Pediatric Tracheostomy TubeHood Laboratories / cleared 1989-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)