Events

Retiro De Equipo (Recall) de Device Recall Rubicor

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 Rubicor Medical.

¿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
    34859
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0715-06
  • Fecha de inicio del evento
    2006-02-17
  • Fecha de publicación del evento
    2006-04-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44835
  • 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
    Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
  • Causa
    Devices' sterility may be compromised due to lack of adequate sterilization.
  • Acción
    On 2/17/06, the firm initiated the recall and its notification was via sales rep retrieval and follow-up letter dated 3/13/06 explaining the reason for the recall and requesting the product be returned.

Device

Device Recall Rubicor
  • Modelo / Serial
    Lot number: 06011817
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide. The product was released for distribution to 19 consignees in US. The firm''s sales force were able to retrieve 18 units, only one (1) was used by a consignee. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, physicians who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
  • Descripción del producto
    Rubicor EnCapsule Breast Biopsy Device, Part Number 31358, || Product is manufactured and distributed by Rubicor Medical, Inc., 600 Chesapeake Dr., Redwood City, CA 94063
  • Manufacturer
    Rubicor Medical

Manufacturer

Rubicor Medical
  • Dirección del fabricante
    Rubicor Medical, 600 Chesapeake Drive, Redwood City CA 94063-1712
  • Source
    USFDA