Events

Retiro De Equipo (Recall) de Device Recall AngioDynamics Morpheus Smart PICC CT

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 Worldwide Headquarters.

¿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
    60909
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0911-2012
  • Fecha de inicio del evento
    2012-01-09
  • Fecha de publicación del evento
    2012-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-02-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106954
  • 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,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Causa
    The red luer on the morpheus ct picc (peripherally inserted central catheter) has the potential to crack during use of the product.
  • Acción
    AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax the form to 518-798-1360. If customers distributed the affected product, they should inform their customers of this recall action immediately and have them return the recalled units to them. For any questions regarding this recall call 1-800-772-6446 or e-mail customerservice@angiodynamics.com.

Device

Device Recall AngioDynamics Morpheus Smart PICC CT
  • Modelo / Serial
    FG Lot Number: 552387, 553194
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide
  • Descripción del producto
    AngioDynamics Special Order Morpheus¿ Smart PICC CT 65cm 6F Dual Lumen with Reverse Taper --- Max CT Flow Rate: 6mL/sec --- Injector Pressure Limit --- Catalog No.: 52102624 --- Made in the USA --- [Manufacturer symbol] AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804 || indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
  • Manufacturer
    Angiodynamics Worldwide Headquarters

Manufacturer

Angiodynamics Worldwide Headquarters
  • Dirección del fabricante
    Angiodynamics Worldwide Headquarters, 14 Plaza Drive, Latham NY 12110-3421
  • Empresa matriz del fabricante (2017)
    AngioDynamics Inc
  • Source
    USFDA