Events

Retiro De Equipo (Recall) de Device Recall Cordis POWERFLEX PRO PTA Dilatation Catheter

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
    70080
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0998-2015
  • Fecha de inicio del evento
    2014-12-22
  • Fecha de publicación del evento
    2015-01-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132222
  • 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
    Catheter, angioplasty, peripheral, transluminal - Product Code LIT
  • Causa
    One unit from a demo lot of powerflex pro pta dilatation catheter was left at a hospital and was not sterilized.
  • Acción
    The firm, Cordis, sent an "URGENT MEDICAL DEVICE RECALL (Removal)" letter dated December 29, 2014 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately check their inventory to confirm they do not have any units from the demo lot in possession; identify and set aside any unit from the identified lot; review, complete, sign and return the enclosed Acknowledgement Form directly to Cordis at the fax number on the form; return any affected product to Cordis; share this letter with others in your facility; contact any other facility that has been provided with units of POWERFLEX PRO product; maintain awareness of this notice until all affected product has been returned to Cordis and keep a copy of this notice witn any affected product. For any physician with medical concerns, please contact the Cordis Endovascular Medical Information Line 877-DEVICES Monday through Friday from 9am-5pm. For questions related to the recall that are not adequately addressed in the letter, please contact the Cordis Field Action Coordinator Hal Baden at (786) 313-2365. For questions related to the Acknowledgement Form and its return, please contact Cordis QA at (786) 313-8730.

Device

Device Recall Cordis POWERFLEX PRO PTA Dilatation Catheter
  • Modelo / Serial
    Catalog 4400615X, demo lot 15617883
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: US including states of: CT, NJ, NY, PA, MD, VA, WV, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, SD, IL, MO, KS, NE, LA, OK, TX, CO, UT, AZ, CA, OR, WA, AR, IN, MN, WY, ND, NV, MA, RI, NH, CT, DE, District of Columbia and Hawaii.
  • Descripción del producto
    Cordis POWERFLEX PRO PTA Dilatation Catheter || Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post- dilatation of balloon-expandable and self-expanding stents in the peripheral 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