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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Recall Number Z-1667-2013
Classification Class I
Code Info The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
Product Distributed Qty 5 units
Reason For Recall The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.

Event Detail

Event Id 65449
Product Type Devices
Status Ongoing
Recalling Firm Bryan Medical Inc
City Cincinnati
State OH
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-17
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Distributed in KY and AL.