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U.S. Department of Health and Human Services

Class 2 Device Recall Portex

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  Class 2 Device Recall Portex see related information
Date Initiated by Firm July 13, 2004
Date Posted July 22, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-1130-04
Recall Event ID 29554
510(K)Number K874597  
Product Classification Condenser, Heat And Moisture (Artificial Nose) - Product Code BYD
Product ThermovenT 600, Heat and Moisture Exchangers
Catalog # 580011
Code Information Lot Numbers 103166A, 103353A, 907001 to 912297, 001067 to 111623, K101587 to K522160 
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Brian Farias
603-352-3812 Ext. 2493
Manufacturer Reason
for Recall		 Sterility of the device is compromised due to lack of package integrity
FDA Determined
Cause 2		 Other
Action Smiths Medical notified Direct Customers were contacted via letter delivered by Federal Express on July 13, 2004. Dealers were contacted via letter starting on July 14, 2004.Users are requested to return product.
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 = BYD and Original Applicant = PORTEX, INC.
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