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U.S. Department of Health and Human Services

Class 2 Device Recall Hyperflex

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  Class 2 Device Recall Hyperflex see related information
Date Initiated by Firm December 16, 2005
Date Posted January 18, 2006
Recall Status1 Terminated 3 on February 08, 2007
Recall Number Z-0394-06
Recall Event ID 34239
510(K)Number K922665  
Product Classification Tube Tracheostomy And Tube Cuff - Product Code JOH
Product Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6.0 mm O.D. 8.7 mm length 110 mm; REF 75HA60.
Code Information Lot G706181.
Recalling Firm/
Smiths Medical ASD, Inc.
5700 W 23rd Ave
Gary IN 46406-2617
For Additional Information Contact Terri Davis
800-848-1757 Ext. 5542
Manufacturer Reason
for Recall
Sterility is compromised by incomplete package seal.
FDA Determined
Cause 2
Action Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
Distribution Nationwide and Canada.
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