FDAFDA · Food and drugs·Recall number Z-1667-2013
Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Published July 17, 2013 · Recall initiated: April 17, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Bryan Medical Inc
- Distributor
- Distributed in KY and AL.
- Lot
- The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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