Events

Retiro De Equipo (Recall) de Device Recall Jejunal Feeding Set

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 Cook 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
    Recall
  • ID del evento
    52758
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1910-2009
  • Fecha de inicio del evento
    2009-07-24
  • Fecha de publicación del evento
    2009-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83888
  • 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
    Gastrointestinal Tubes and Accessories - Product Code KNT
  • Causa
    The english only version of the patient care manuals that accompany the device were shipped to a medical facility in italy.
  • Acción
    The consignee was notified by an Urgent: Field Safety Notice, dated 07/24/2009. The distributor (Cook Ireland) was instructed to contact the Italian Company Representative. The appropriate Patient Care Manual with the Italian translation was provided to the medical facility with the assistance of the Area Representative. The Area Representative instructed the medical facility staff to provide the translated Patient Care Manual to the caregiver(s) of the patient that received the Jejunal Feeding Sets. The distributor is already aware of the situation. The lower portion of the letter was to be filled out and sent to Cook Endoscopy.

Device

Device Recall Jejunal Feeding Set
  • Modelo / Serial
    Lot number W2676476
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International Only Distribution -- Country of Italy.
  • Descripción del producto
    Jejunal Feeding Set, Product Order number FLOWJ-9-20. || This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Dirección del fabricante
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA