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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 February 17, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 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/
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 2
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