Events

Rappel de Device Recall FloTrac Sensor

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 Edwards Lifesciences, LLC.

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
    65984
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2189-2013
  • Date de mise en oeuvre de l'événement
    2013-07-31
  • Date de publication de l'événement
    2013-09-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121142
  • 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
    Transducer, blood-pressure, extravascular - Product Code DRS
  • Cause
    The edwards lifesciences flotrac sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the ifu was placed on top of the tyvek instead of being placed at the bottom of the box. there is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
  • Action
    Edwards Lifesciences initiated a US recall via an Urgent Product Recall letter dated July 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that an Edweards Lifesciences representative would come to their facility to retrieve the affected device. A device replacement would be provided to the customer. Customers were asked to complete the enclosed Confirmation Form and give it to the Edwards Lifesciences representative that will come to their facility. For customers with questions were instruct4ed to call Edwards Customers Service at 1-800-424-3278. For questions regarding this recall call 972-410-7100.

Device

Device Recall FloTrac Sensor
  • Modèle / numéro de série
    595531157
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including MO and MI.
  • Description du dispositif
    "***Flo Trac Sensor Model MHD85***" || Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC