Reported Jul 17, 2013 · Terminated

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

Bryan Medical Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bryan Medical Inc · 6811 Mount Vernon Ave · Cincinnati, OH · 45227

Is this the product you have?

  • Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Lot codes and dates
  • The following product/catalog
  • number and lot number was affects
    • Ref #350-3.0
    • lot #000-1000071752
Amount recalled
5 units

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 29, 2013 · Data as of Sep 19, 5:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.