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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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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
Distribution Pattern Distributed in KY and AL.

Product Detail

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