Events

Rappel de Device Recall PREFACE

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 Biosense Webster, 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
    36988
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0541-2007
  • Date de mise en oeuvre de l'événement
    2006-11-17
  • Date de publication de l'événement
    2007-02-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2009-06-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49717
  • 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
    intravascular guiding sheath - Product Code DYB
  • Cause
    Biosense webster, inc. has received a number of complaints regarding the radiopaque tip separating or partially detaching from the preface sheath during use in the left atrium.
  • Action
    Initially a Medical Device Correction Advisory letter was mailed on November 20, 2006 to all domestic and international consignees recommending to customers that the Preface Sheath was not to be used with the NaviStar ThermoCool Catheter or any 8 French or larger catheter. On December 9, 2006, a Recall Customer letter and Certification form were sent out to all customers and Johnson & Johnson affiliates who had purchased the product in the past three years. For customers in the US, two letters and forms were sent out -one addressed to the EP/Cardiology Lab and the second to the Risk Management Office. For the US, customers will return product directly to Biosense Webster afler receiving a return authorization number. Returned product will be segregated and labeled as quarantined product. Returned product will be used as necessary for the root cause investigation. Any product not used at the conclusion of the investigation will be destroyed. For international customers, product will be returned to the Biosense Webster warehouse in Roden, Netherlands or to the Biosense Webster US warehouse (depending on order placement) if export issues don''t present a problem. If product cannot be easily returned to Biosense Webster, the customers will be instructed to destroy the product and provide notification that the destruction was performed.

Device

Device Recall PREFACE
  • Modèle / numéro de série
    Lot numbers: 13073871, 13085576, L0103109, L0203006, L0206046, L0206153, L0306085, L0504274, L0604126, L0702465, L0704300, L0802224, L0802580, L0804091 & L0902619
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution, including USA, Australia, Brazil, Canada, China, Colombia, Hong Kong, Indonesia, Israel, India, Japan, Korea, the Netherlands, New Zealand, Pakistan, Singapore, Thailand, and Taiwan.
  • Description du dispositif
    Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Adresse du fabricant
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA