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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Bivona Adult Trach Tube

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  Class 2 Device Recall Smiths Bivona Adult Trach Tube see related information
Date Initiated by Firm August 31, 2006
Date Posted January 05, 2007
Recall Status1 Terminated 3 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/
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 2
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