Events

Retiro De Equipo (Recall) de Device Recall Temno

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 Carefusion 2200 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
    56085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2111-2010
  • Fecha de inicio del evento
    2010-06-25
  • Fecha de publicación del evento
    2010-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92609
  • 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
    Guide, needle, surgical - Product Code GDF
  • Causa
    The introducer needle is only 10 cm in length instead of the required 15 cm.
  • Acción
    Cardinal Health, on behalf of CareFusion, telephoned the customers on June 15, 2010 and sent a follow-up "URGENT: PRODUCT RECALL" letter on the same date via UPS next day air. The letter describes product, problem, and action taken by customers. The customers were instructed to immediately stop using affected product, return the enclosed acknowledgment form via fax to 847-686-9101 (note: Cardinal Health is required to confirm receipt of this notification from the customers), notify any customers to whom they may have distributed product to, contact CareFusion Customer Service at 800-653-6827 to arrange for credit and return of the affected product, and send the affected product to CareFusion, 1240 Waukegan Rd, Waukegan, IL 60085, Attn: Scott Fitzer, after obtaining an RMA/RGA number from CareFusion. If you have any questions, please contact 800-292-9332.

Device

Device Recall Temno
  • Modelo / Serial
    Catalog number CCH2220, Lot D09121745
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution: California, Florida, Georgia, Illinois, Kentucky, Massachusetts, New Jersey, New York and Pennsylvania.
  • Descripción del producto
    Temno Coaxial Chiba Fine Needle Aspiration; a coaxial introducer needle (20G x 15 cm) with a Chiba biopsy needle (22G x 20 cm); sterile, for single use only sets, 5 sets per case; CareFusion, McGaw Park, IL 60085 USA, Made in Dominican Republic; REF CCH2220 || For use in soft tissue aspiration such as breast, kidney, liver, lung, thyroid, lymph nodes and other various soft tissue masses. It is not intended for use in the bone.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • Dirección del fabricante
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA