Events

Rappel de Device Recall Edwards Lifesciences Suction Wand

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
    65492
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1749-2013
  • Date de mise en oeuvre de l'événement
    2013-06-19
  • Date de publication de l'événement
    2013-07-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119271
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Cause
    Edwards is recalling certain lots of rigid suction wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
  • Action
    Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.

Device

Device Recall Edwards Lifesciences Suction Wand
  • Modèle / numéro de série
    Models S099 and S099B
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Description du dispositif
    Edwards Lifesciences Suction Wand, models S099 and S0998B || Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Adresse du fabricant
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Société-mère du fabricant (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA