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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Portex

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  Class 2 Device Recall Smiths Portex see related information
Date Initiated by Firm September 18, 2007
Date Posted November 07, 2007
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0100-2008
Recall Event ID 44792
510(K)Number K031057  
Product Classification Tracheostomy Tube - Product Code JOH
Product Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile
Ref: 536090
Code Information Lot Number: 1155185
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact SAME
603-352-3812
Manufacturer Reason
for Recall		 Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
FDA Determined
Cause 2		 Process control
Action Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.
Quantity in Commerce 40 units
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 = JOH and Original Applicant = PORTEX, INC.
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