Events

Retiro De Equipo (Recall) de Device Recall PREFACE

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biosense Webster, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    36988
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0541-2007
  • Fecha de inicio del evento
    2006-11-17
  • Fecha de publicación del evento
    2007-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-06-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49717
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    intravascular guiding sheath - Product Code DYB
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Lot numbers: 13073871, 13085576, L0103109, L0203006, L0206046, L0206153, L0306085, L0504274, L0604126, L0702465, L0704300, L0802224, L0802580, L0804091 & L0902619
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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.
  • Descripción del producto
    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.
  • Dirección del fabricante
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA