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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 January 26, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0572-04
Recall Event ID 28183
510(K)Number k902180  
Product Classification Stylet, Tracheal Tube - Product Code BSR
Product Portex Tracheal Tube Guide 15 Fr, non-sterile
Catalog Number: 153013
Code Information Lot Number: K221961
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. 2457
Manufacturer Reason
for Recall		 Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr
FDA Determined
Cause 2		 Other
Action Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter.
Quantity in Commerce 46 cases (230 UNITS)
Distribution CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA
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 = BSR and Original Applicant = SIMS SURGICAL, INC.
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