Class 2 Device Recall Portex

• Date Initiated by Firm: July 13, 2004
• Date Posted: July 22, 2004
• Recall Status: Terminated on May 08, 2012
• Recall Number: Z-1129-04
• Recall Event ID: 29554
• 510(K)Number: K874597
• Product Classification: Condenser, Heat And Moisture (Artificial Nose) - Product Code BYD
• Product: Portex Thermovent T, Heat and Moisture Exchangers Catalog # 570016
• 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: 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