Events

Retiro De Equipo (Recall) de Device Recall AngioDynamics SmartPort

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 Angiodynamics, 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
    52762
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1898-2009
  • Fecha de inicio del evento
    2009-07-16
  • Fecha de publicación del evento
    2009-09-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-10-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83901
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Causa
    The product may contain an incorrect size catheter and introducer.
  • Acción
    Notification of the AngioDynamics, Inc. sales force began on July 16, 2009 and they were asked to assist in the return of all affected devices to the Manchester, GA division of AngioDynamics, Inc. Urgent Recall letters were sent to all customers on July 16, 2009, requesting the completion of a FAX BACK form. Those currently in possession of any remaining devices will be provided a Return Goods Authorization (RGA) number and pre-paid shipping boxes for return of the product to AngioDynamics, Inc. All returned devices will be physically and electronically quarantined until final disposition of the devices. All devices will be inspected for damage to the devices and any damaged devices destroyed (scrapped) via the AngioDynamics procedure for Disposition of Nonconformances, procedure. Non-damaged product may be reworked to remove the incorrect catheter and introducer and replaced with the correct catheter and introducer, repackaged and re-sterilized in accordance with the AngioDynamics procedure for Rework. If necessary, follow-up letters, phone calls or visits by the AngioDynamics sales representatives may be used to complete the effective checks. Level A (100%) of consignees to be contacted). Please contact your local representative or Recall Coordinator at 1-706-846-3126, for assistance. You may e-mail your questions to customerservice@angiodynamics.com.

Device

Device Recall AngioDynamics SmartPort
  • Modelo / Serial
    Lot number: 983533
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MI, MO, MN, MS, NC, NY, OH, OR, PA, TN and TX.
  • Descripción del producto
    SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated || The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood.
  • Manufacturer
    Angiodynamics, INC

Manufacturer

Angiodynamics, INC
  • Dirección del fabricante
    Angiodynamics, INC, 1 Horizon Way, Manchester GA 31816-1749
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    USFDA