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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 September 09, 2004
Date Posted November 24, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0238-05
Recall Event ID 29990
510(K)Number K851986  
Product Classification Stopcock, I.V. Set - Product Code FMG
Product Portex 4 Way ''T-Handle'' Stopcock
Catalog Number: T1204
Code Information Lot numbers starting with: 0, 1, 909, 911, 912, K1 
Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
For Additional Information Contact Timothy J. Talcott
603-352-3812 Ext. 2667
Manufacturer Reason
for Recall
Sterility of the device is compromised due to packaging defects
FDA Determined
Cause 2
Other
Action Smiths Medical, ASD notified consignees by letter dated September 9, 2004 by FedEx. Customers and dealers are directed to fax back the attached Reply Letter to the Smiths Medical Regulatory Affairs Department at 603-358-1017, even if the customer/dealer no longer has affected products in inventory, Questions are directed to Customer Service at 1-800-258-5361, prompt 1. On 9/17/04, Smiths notified 48 consignees by Fed''X letter of 3 -additional lot codes for Product Code: 4252.
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 = FMG and Original Applicant = TRANSAMERICA DELAVAL, INC.
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