Events

Retiro De Equipo (Recall) de Device Recall AMPLATZER Delivery Systems

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 AGA Medical 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
    30481
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0361-05
  • Fecha de inicio del evento
    2004-11-23
  • Fecha de publicación del evento
    2004-12-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36280
  • 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
    unknown device name - Product Code GBK
  • Causa
    Tubing utilized in the manufacture of the amplatzer delivery and exchange system sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing.
  • Acción
    Recall notices were sent via e-mail 11/22/04 to physicians, hospitals and distributors who received affected product. Hard copies of the Recall Notices were sent to all customers (international and domestic) via Federal Express 11/22-24/04. A form that is attached to the Recall Notice asks for customers to fill out quantities of affected product and to return the affected product to AGA Medical.

Device

Device Recall AMPLATZER Delivery Systems
  • Modelo / Serial
    M01L17-02, M02A28-21, M02A28-24, M02K07-46, M03G10-30,  M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24,  M04H03-20, M04K26-18
  • Distribución
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Descripción del producto
    AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • Dirección del fabricante
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA