Events

Retiro De Equipo (Recall) de Device Recall The EnCor biopsy probe

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 Bard Peripheral Vascular 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
    60347
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0351-2012
  • Fecha de inicio del evento
    2011-11-03
  • Fecha de publicación del evento
    2011-12-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105125
  • 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
    Instrument, biopsy, suction - Product Code FCK
  • Causa
    This recall was voluntarily initiated by the firm due to the product 's damaged packaging trays; cracked encor (trademark) packaging trays, plastic petg tray the probe is packaged in was cracked.
  • Acción
    The firm sent the customer notification letter on 11/07/11, via FedEx with proof of delivery notice. The letter notified customers of the reason for recall that units from the affected lot may have packaging damage resulting from transportation. The letter instructed customers to check all inventory locations , remove any identified product, to not use the affected product, and return the affected product to Bard Peripheral Vascular, Inc., 1415 W. 3rd Street, Tempe, Arizona 85281. The letter also instructed customers to fill out the recall and effectiveness check form and fax it to 1-800-894-6772. Customers were instructed to call 1-800-321-4254, Option #2 Ext 2727 for a return authorization number to facilitate the expedient return of the product. For questions regarding this recall call 480-894-9515

Device

Device Recall The EnCor biopsy probe
  • Modelo / Serial
    ECP0110G, ECP017G, ECP0112G, ECPMR0110G, ECP017GV, ECPMR0110GBT, ECP0112GV, ECPMR017G.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and the countries of Canada, Europe, LAPAC, and Australia
  • Descripción del producto
    The EnCor¿ biopsy probe, designed for use with EnCor¿ and EnCor¿ Enspire Vacuum Assisted Biopsy (VAB) driver systems. || The EnCor¿ Biopsy Device is indicated for use in acquiring tissue for diagnosing breast abnormalities and is supplied sterile and intended for single use.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Dirección del fabricante
    Bard Peripheral Vascular Inc, 1625 W 3rd St, Tempe AZ 85281-2438
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA