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U.S. Department of Health and Human Services

Class 3 Device Recall SIMS/Portex

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  Class 3 Device Recall SIMS/Portex see related information
Date Initiated by Firm June 18, 2003
Date Posted July 23, 2003
Recall Status1 Terminated 3 on March 31, 2004
Recall Number Z-1039-03
Recall Event ID 26621
510(K)Number K922749  
Product Classification Tube, Tracheostomy (W/Wo Connector) - Product Code BTO
Product Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm
Catalog Number: 593090
Code Information Lot Number: 905486 EXP: 2004-05
Recalling Firm/
Manufacturer		 Portex Inc.
10 Bowman Drive
Keene NH 03431
For Additional Information Contact Timothy Talcott
603-352-3812
Manufacturer Reason
for Recall		 Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
FDA Determined
Cause 2		 Other
Action Portex notified four user facilities by telephone on June 18th and 19th, 2003 . The consignees were instructed to check their inventory for any affected product and to call to make arrangements for the return and credit of the affected product. If the product was in use, they were instructed to remove the fenestrated label on the inflation line and to inform the patient and healthcare provider of the discrepancy.
Quantity in Commerce 11 units
Distribution CA, GA, KA, MO
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 = BTO and Original Applicant = CONCORD/PORTEX
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