Events

Recall of Device Recall Portex Uncuffed Paediatric Sized Tracheal Tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53075
  • Event Risk Class
    Class 1
  • Event Number
    Z-2056-2009
  • Event Initiated Date
    2009-08-25
  • Event Date Posted
    2009-09-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84583
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tube, tracheal (w/wo connector) - Product Code BTR
  • 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.

Device

Device Recall Portex Uncuffed Paediatric Sized Tracheal Tube
  • Model / Serial
    Product manufactured before September 2009 and within its expiration date.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    Portex¿ Uncuffed Paediatric Sized Tracheal Tube || Oral Nasal, Ivory 3.5 mm, || Product Code: 100/105/035. || Intended for oral and/or nasal intubation for airway management.
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical
  • Manufacturer Address
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    USFDA