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U.S. Department of Health and Human Services

Class 3 Device Recall Portex

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  Class 3 Device Recall Portex see related information
Date Initiated by Firm March 07, 2006
Date Posted April 06, 2006
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0714-06
Recall Event ID 34762
510(K)Number K030381  
Product Classification Tracheostomy Tube - Product Code BTO
Product Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula
REF 100/858/080
Code Information Lot 490694
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Timothy J. Talcott
2457-603-352-3812 Ext. 4
Manufacturer Reason
for Recall		 Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
FDA Determined
Cause 2		 Other
Action Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.
Quantity in Commerce 5350 units (107 cases)
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 = PORTEX LTD.
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