Retiro De Equipo (Recall) de Device Recall Minor Dressing 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 Centurion Medical Products.

¿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
    Kit, i.V. Start - Product Code LRS
  • Causa
    The firm is conducting a recall of kits that contain the monoject prefill advanced flush syringes containing heparin. the syringes are under recall by their manufacturer coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium usp contained low level of over-sulfated chondroitin sulfate (oscs)".
  • Acción
    The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: or fax: 302-822-6009.


  • Modelo / Serial
    2009111880, 2010020880, 2009121680, 2010021680, 2009121580, 2009111780, 2009111680, 2010011880, 2010021580.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.
  • Descripción del producto
    Minor Dressing Tray, Reorder DT14405, Sterile, Centurion Medical Products Corp. Williamston, MI || Intended use: Vascular access port kit
  • Manufacturer


  • Dirección del fabricante
    Centurion Medical Products, 301 Catrell Dr, Howell MI 48843-1703
  • Empresa matriz del fabricante (2017)
  • Source