Events

Rappel de Device Recall Rusch

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
    60583
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0517-2012
  • Date de mise en oeuvre de l'événement
    2011-12-02
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105882
  • 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
    Stylet, tracheal tube - Product Code BSR
  • Cause
    Complaints of difficulty removing stylet from the endotracheal tube and possible pvc sheath separation were received.
  • Action
    The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated December 2, 2011 to its Consignees/Customers. The letter described the product, problem and actions to be take. The customers were instructed to immediately discontinue use and quarantine any products with the listed catalog and lot numbers; return the product; complete and return the enclosed Immediate Attention Requested Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customer Service (a customer service representative will contact the customer with a returns good authorization number and provide instructions for the return of product to Teleflex medical), even if they have no affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall Rusch
  • Modèle / numéro de série
    Catalog numbers: 502501, Lot numbers: 10JG05, 10JG28, 10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25, 11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21, 11FE24, 11GE29, 11GE30 and 11GG41.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada and Europe.
  • Description du dispositif
    Rusch Flexi-slip Endotracheal Tube Stylet with Soft Distal Tip, 6FR, Catalog numbers: 502501, Teleflex Medical Sdn Bhd, P.O. Box, Industrial Estate, 24600 Kamunting, Perak, Malaysia. || Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Adresse du fabricant
    Teleflex Medical, 2917 Weck Dr., Research Triangle Park NC 27709
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA