Retiro De Equipo (Recall) de Device Recall LifeStent 6mm LP SDS Billiary Endoprosthesis

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 Orbus Medical Technologies 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
    29074
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1075-04
  • Fecha de inicio del evento
    2004-03-19
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-07-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    unknown device name - Product Code MEW
  • Causa
    Balloons have longer than expected deflation times.
  • Acción
    Orbus, the recalling firm issued a recall letter on March,19 2004 to their own label distributer, Edwards Lifesciences, requesting the return of unused product. Also Orbus provided the own label distributer with a sample sub-recall letter for them to send to users/hospital accounts. Sub-accounts were asked to return product to Edwards Lifesciences.

Device

  • Modelo / Serial
    Lot numbers, FA0311031, FA0311032, FA0311034, FA0311035, FA0312026, FA0312034, FA0312041, FA0312042, FA0312051, FA0312052, FA0401006, FA0401019, FA0401026, FA0402026
  • Distribución
    Product was shipped to one own label distributer in California.
  • Descripción del producto
    The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. || The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. || Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. || Ref. Baloon-Expandable Stent and delivery System. || Catalog Numbers || SD186U14D || SD186U24D || SD366U14D || SD366U24D
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Orbus Medical Technologies Inc, 5363 NW 35th Ave, Fort Lauderdale FL 33309-6315
  • Source
    USFDA