Events

Retiro De Equipo (Recall) de Device Recall MassTRANSIT Infusion Catheter Kit

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 Cordis Corporation.

¿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
    50154
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0604-2009
  • Fecha de inicio del evento
    2008-06-30
  • Fecha de publicación del evento
    2008-12-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74869
  • 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
    Continuous Flush Catheter - Product Code KRA
  • Causa
    Two lots of cordis neurovascular masstransit infusion catheter kits has the potential for sterile ptfe contamination within the inner lumen of the catheter.
  • Acción
    A Medical Device Recall letter, dated 6/30/2008, and Acknowledgement Form were sent overnight. The firm asked customers to set aside any affected product in a manner that ensures it will not be used. Customers are asked to review, sign and return the enclosed Acknowledgement Form directly to Cordis Neurovascular. Customers can either return any product with reference to the RA# on the form, or contact their local sales reps to facilitate return of the affected product. Customers will receive a credit for the units they return. If any affected product has been forwarded to another facility, the facility should be contacted to arrange return of the product. If there are any additional questions, Customer Service may be also be contacted at 800-551-7683.

Device

Device Recall MassTRANSIT Infusion Catheter Kit
  • Modelo / Serial
    Lot Number 13358689 and 13350390.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of Colorado, Connecticut, Florida, Minnesota, Nebraska, Nevada, Ohio, Oregon, and Virginia.
  • Descripción del producto
    MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis Neurovascular || Intended to be used as a mechanism for the infusion of various diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral Vascular and Coronary Vascular systems and for superselective angiography of peripheral and coronary vasculature.
  • Manufacturer
    Cordis Corporation

Manufacturer

Cordis Corporation
  • Dirección del fabricante
    Cordis Corporation, 14201 Nw 60th Ave, Miami Lakes FL 33014-2802
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA