FDA-Device2013-07-17Class I

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

Bryan Medical Inc
Hazard

The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Sold states
Distributed in KY and AL.
Affected count
5 units
Manufactured in
6811 Mount Vernon Ave, N/A, Cincinnati, OH, United States
Products
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1667-2013

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief