Retiro De Equipo (Recall) de Device Recall CORFLOUltra Jejunal Tube with CORLOCKTwoomey YAdaptor

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 Corpak Med Systems.

¿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
    61036
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1080-2012
  • Fecha de inicio del evento
    2012-01-26
  • Fecha de publicación del evento
    2012-02-22
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2012-03-21
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Causa
    The wrong size twoomey adapter was packaged with the jejunal tube.
  • Acción
    Corpak MedSystems telephoned customers on January 26, 2012 and sent a follow-up Recall Notification letter dated January 27, 2012 via e-mail reiterating the telephone conversations. Customers were informed of the urgent product recall, the problem and the actions to be taken. Customers were instructed to inspect inventory, segregate any affected product and contact Corpak at 1-800-323-6305 to arrange for the return and replacement of the units found. Customers were advised to complete and return the enclosed acknowledgment form, indicating the number of affected units found in their inventory. Distributors were requested to notify their customers. For questions contact Corpak MedSytems at 1-800-403-3400.

Device

  • Modelo / Serial
    catalog/reorder #30-7361, lot 46121, expiration: 2016-10
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including the states of Georgia, Indiana, Kentucky, Maryland, Michigan, Minnesota, Tennessee, Utah and the countries of to Sweden and New Zealand.
  • Descripción del producto
    CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral feeding tube,10 Fr, 36" (91 cm), 3 Gram weighted bolus; individually packaged, 5 tubes per case; CORPAK MedSystems, Wheeling, IL 60090; catalog/reorder #30-7361; For delivery of enteral nutrition || Product Usage: For delivery of enteral nutrition
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Corpak Med Systems, 1001 Asbury Dr, Buffalo Grove IL 60089
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA