Z-1667-2013 Class I Terminated

Recalled by Bryan Medical Inc — Cincinnati, OH

Recall Details

Product Type
Devices
Report Date
July 17, 2013
Initiation Date
April 17, 2013
Termination Date
October 29, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Distributed in KY and AL.

Code Information

The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752