Class 2 Device Recall

• Date Initiated by Firm: February 17, 2005
• Date Posted: December 23, 2005
• Recall Status: Terminated on December 04, 2007
• Recall Number: Z-0302-06
• Recall Event ID: 32917
• 510(K)Number: K914088
• Product Classification: Tube, Tracheostomy (W/Wo Connector) - Product Code BTO
• Product: Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
• Code Information: Lot 1338010.
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 5700 W 23rd Ave; Gary IN 46406-2617
• For Additional Information Contact: 800-424-8662 Ext. 6
• Manufacturer Reason for Recall: The word PED was printed on the neckflange instead of the word NEO.
• FDA Determined Cause: Other
• Action: Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.
• Quantity in Commerce: 26
• Distribution: Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
• 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 and Original Applicant = BIVONA MEDICAL TECHNOLOGIES