Class 2 Device Recall

• Date Initiated by Firm: April 26, 2005
• Date Posted: June 25, 2005
• Recall Status: Terminated on October 26, 2005
• Recall Number: Z-0930-05
• Recall Event ID: 31856
• 510(K)Number: K914088
• Product Classification: Tube Tracheostomy And Tube Cuff - Product Code JOH
• Product: Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Code Information: Lot G651610.
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 5700 W 23rd Ave; Gary IN 46406-2617
• For Additional Information Contact: 800-424-8662
• Manufacturer Reason for Recall: The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
• FDA Determined Cause: Other
• Action: Consignees were notified via letter dated 4/26/05.
• Quantity in Commerce: 48
• Distribution: Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
• 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 = JOH