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U.S. Department of Health and Human Services

Class 1 Device Recall Portex Tracheal Tube

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  Class 1 Device Recall Portex Tracheal Tube see related information
Date Initiated by Firm August 25, 2009
Date Posted September 18, 2009
Recall Status1 Terminated 3 on November 16, 2012
Recall Number Z-2061-2009
Recall Event ID 53075
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Portex¿ Tracheal Tube, Oral/Nasal, Siliconized, 3.5 mm
Product Code: 100/111/035.

Intended for oral and/or nasal intubation for airway management.
Code Information Product manufactured before September 2009 and within its expiration date.
Recalling Firm/
Manufacturer
Smiths Medical
Hythe
Hythe, Kent United Kingdom
For Additional Information Contact SAME AS RECALL CONTACT
603-352-3812
Manufacturer Reason
for Recall
Pediatric Trachel Tube manufactured with internal diameter smaller than indicated in the label may result in inability to remove secretions and cause partial or complete obstruction of the airway
FDA Determined
Cause 2
Process control
Action Smiths Medical issued an "Urgent Field Safety Notice" dated August 24, 2009 via UPS Second Day Mail including a Guidance Chart. Return of the enclosed Confirmation Form was also requested by fax to 1-603-355-8157. Smiths Medical issued a revised recall letter dated September 9, 2009. Customers are requested to return unused affected product to the firm. For further information, contact Smiths Medical ASD, Inc. by phone at 1-800-348-6064, prompt 4 extension 2273.
Quantity in Commerce 64,909 (US) 657,610 (International)
Distribution Worldwide Distribution -- United States, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Borneo, Brazil, Brunei, Bulgaria, Canada, Chile, China, C¿¿te d'Ivoire, Czech Republic, Denmark, East Timor, Egypt, Estonia, Finland, France, Georgia, Germany, Gibraltar, Greece, Guatemala, Vatican City, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Malaysia, Maldives, Malta, Mexico, New Zealand, Netherlands, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom and Uruguay.
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.
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