Events

Retiro De Equipo (Recall) de Device Recall ENDOTINE Forehead

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 Coapt Systems, 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
    26449
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1002-03
  • Fecha de inicio del evento
    2003-05-23
  • Fecha de publicación del evento
    2003-07-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2003-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27704
  • 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 ---
  • Causa
    During use, the device has a potential for unacceptable deep hole in the cranium which can cause patient injury.
  • Acción
    On 5/19/03, the firm issued letters via overnight express to all its consignees, informing them of the affected devices and providing instructions on the recall.

Device

Device Recall ENDOTINE Forehead
  • Modelo / Serial
    Lot Numbers: 00045, 00085 and 00092
  • Distribución
    These products were distributed nationally to 107 consignees and internationally to 2 consignees via distributors and directly to physicians and/or medical facilities. The total number of devices distributed subject to the removal by lot numbers: lot 00045: 19 units; lot 00085: 94 units; and lot 00092: 160 units. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, physicians and/or medical facilities who received the recalled products. There is no known U. S. Government or Canadian distribution.
  • Descripción del producto
    Drill bits used in ENDOTINE Forehead¿ 3.5 and 3.0, Catalog Number: CFD-010-4203 and CFD-010-4303
  • Manufacturer
    Coapt Systems, Inc.

Manufacturer

Coapt Systems, Inc.
  • Dirección del fabricante
    Coapt Systems, Inc., 1820 Embarcadero Rd., Palo Alto CA 94303
  • Source
    USFDA