Events

Rappel de Device Recall ThinFlex Venous Return Cannulae with Duraflo coating

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 Research Medical, Inc..

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
    49049
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2403-2008
  • Date de mise en oeuvre de l'événement
    2008-07-14
  • Date de publication de l'événement
    2008-09-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72608
  • 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
    Cannula and Tubing Vascular Catheter - Product Code DWF
  • Cause
    Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.
  • Action
    All domestic consignees were notified by a Product Recall letter on 07/15/2008 via FedEx. They were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards. Customers are to contact Customer Service Organization to obtain a Returned Goods Authorization number and replacement product. Once inventory has been verified, the attached form needs to be completed and faxed to Edwards so that customer awareness can be confirmed. International accounts were notified on 07/14/2008.

Device

Device Recall ThinFlex Venous Return Cannulae with Duraflo coating
  • Modèle / numéro de série
    Lot Number 58440709
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution --- USA including states of AL, CA, LA, MI, MN, MO, MS, NC, ND, SC, TX, and WA, and countries of Brazil, Israel, Japan, and Netherlands.
  • Description du dispositif
    Thin-Flex Venous Return Cannulae with Duraflo coating, REF DTF3343O, 33/43 Fr. x 39 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulation for a duration of less than and equal to 6 hours.
  • Manufacturer
    Edwards Lifesciences Research Medical, Inc.

Manufacturer

Edwards Lifesciences Research Medical, Inc.
  • Adresse du fabricant
    Edwards Lifesciences Research Medical, Inc., 6864 South 300 West, Midvale UT 84047
  • Société-mère du fabricant (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA