Retiro De Equipo (Recall) de Device Recall 45cm Laparoscopic Instruments Sterilization tray

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 Stryker Endoscopy.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Causa
    During testing and review, stryker endoscopy discovered that the sterilization parameters for the 132 degree c gravity steam sterilization cycle in the ifu may not consistently sterilize all instruments in the 45cm laparoscopic instruments tray.
  • Acción
    Stryker Endoscopy sent a "URGENT: DEVICE CORRECTION" letter dated June 8, 2011 to affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were instructed to discard all old Instructions for Use sheets for their 45cm Laparoscopic Tray and download the new IFU from the URL link: tray. Additionally, customers were instructed to complete and return an attached "acknowledgement of receipt" form and fax to 408-754-8378 or scan and e-mail to Questions can be answered by calling 1-800-624-4422 or by e-mail at


  • Modelo / Serial
    Model number 250-015-704. All serial/lot numbers.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution--USA (nationwide) and countries of Brazil, Canada, Chili, Germany , Korea, Mexico, Philippines, Poland, Portugal, Singapore, Sweden, Switzerland, and Taiwan.
  • Descripción del producto
    45cm Laparoscopic Instruments Sterilization tray. || Manufactured by: Stryker Endoscopy, 5900 Optical Court,San Jose, CA 95138 || Designed to hold laparoscopic surgical manual instruments which are intended for cutting, holding, grasping and manipulating tissue, organs, organ area, surgical auxiliaries such as suturing material. The 45cm Lap tray can hold up to 11 instruments in the top tier and a combination of instruments in the bottom tier provided that the total weight of the loaded tray does not exceed 6.53 kg.
  • Manufacturer


  • Dirección del fabricante
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
  • Source