Events

Rappel de Sheridan Preformed Cuffed Oral Tracheal Tube 5.0 mm

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 Teleflex 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
    36426
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0127-2007
  • Date de publication de l'événement
    2006-11-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-08-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48636
  • 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
    Tracheal Tube - Product Code BTR
  • Cause
    Biological indicator failed. investigation eliminated all equipment and product related factors.
  • Action
    Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Device

Sheridan Preformed Cuffed Oral Tracheal Tube 5.0 mm
  • Modèle / numéro de série
    catalog number (REF) 5-22210, lot number 1189023
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
  • Description du dispositif
    Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2345 Waukegan Rd Ste 120, Bannockburn IL 60015-1580
  • Source
    USFDA