Class 2 Device Recall Smiths Bivona Adult Trach Tube

• Date Initiated by Firm: August 31, 2006
• Date Posted: January 05, 2007
• Recall Status: Terminated on May 04, 2007
• Recall Number: Z-0339-2007
• Recall Event ID: 36693
• 510(K)Number: K913859
• Product Classification: Tracheostomy tube - Product Code JOH
• Product: Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
• Code Information: Lots 1008187, 1023402 and 1012767.
• Recalling Firm/ Manufacturer: Smiths Medical ASD, Inc.; 5700 W 23rd Ave; Gary IN 46406-2617
• For Additional Information Contact: 800-858-7670 Ext. 5566
• Manufacturer Reason for Recall: Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
• FDA Determined Cause: Other
• Action: Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.
• Quantity in Commerce: 197
• Distribution: Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.
• 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 and Original Applicant = BIVONA MEDICAL TECHNOLOGIES