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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 25, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-0301-06
Recall Event ID 32915
510(K)Number K894614  
Product Classification Tube, Tracheostomy (W/Wo Connector) - Product Code BTO
Product Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Code Information Lot G667991.
Recalling Firm/
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
Instructions for use included in the package are for a different tracheostomy tube.
FDA Determined
Cause 2
Action Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.
Quantity in Commerce 91
Distribution Nationwide.
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