BEUDAMED
    FDA Recall Terminated

    Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm Product Code: 100/111/030. Intended for oral and/or nasal intubation for airway management.

    Recall: Z-2060-2009 · Initiated August 25, 2009

    Recall

    Recall Number
    Z-2060-2009
    Event Number
    53075
    Firm
    Smiths Medical Hythe Hythe, Kent United Kingdom
    FEI Number
    3002807908
    Product Code
    BTR
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 25, 2009
    Posted
    September 18, 2009
    Terminated
    November 16, 2012

    Description

    Portex Tracheal Tube, Oral/Nasal, Siliconized, 3.0 mm Product Code: 100/111/030. Intended for oral and/or nasal intubation for airway management.

    Reason

    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

    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.

    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.

    Quantity

    52,747 (US) 615,430 (International)