Events

Rappel de Device Recall Portex Polar Preformed Tracheal Tube

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smiths Medical.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53075
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2072-2009
  • Date de mise en oeuvre de l'événement
    2009-08-25
  • Date de publication de l'événement
    2009-09-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85105
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Tube, tracheal (w/wo connector) - Product Code BTR
  • Cause
    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 Polar Preformed Tracheal Tube
  • Modèle / numéro de série
    Product manufactured before September 2009 and within its expiration date.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    Portex¿ Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm || Product Code: 100/134/035. || Intended for oral and/or nasal intubation for airway management.
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical
  • Adresse du fabricant
    Smiths Medical, Hythe, Hythe, Kent United Kingdom
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA