Class 1 Device Recall Tracoe Mini 3.0mm tracheostomy tube.

• Date Initiated by Firm: April 17, 2013
• Date Posted: July 08, 2013
• Recall Status: Terminated on October 29, 2013
• Recall Number: Z-1667-2013
• Recall Event ID: 65449
• 510(K)Number: K893866
• Product Classification: Tube, tracheostomy (w/wo connector) - Product Code BTO
• Product: Tracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
• Code Information: The following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
• FEI Number: 3005803389
• Recalling Firm/ Manufacturer: Bryan Medical Inc; 6811 Mount Vernon Ave; Cincinnati OH 45227
• For Additional Information Contact: Andrew J. Georgilis; 513-272-1600
• Manufacturer Reason for Recall: The pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
• FDA Determined Cause: Labeling Change Control
• Action: The consignees were contacted by telephone and asked to return the recalled product.
• Quantity in Commerce: 5 units
• Distribution: Distributed in KY and AL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTO