Events

Retiro De Equipo (Recall) de Device Recall Kii Shielded Bladed Access System

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 Applied Medical Resources Corp.

¿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
    63842
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0644-2013
  • Fecha de inicio del evento
    2012-11-05
  • Fecha de publicación del evento
    2013-01-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114879
  • 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
    Laparoscope, general & plastic surgery - Product Code CGJ
  • Causa
    Applied medical is conducting a voluntary recall on a specific lot number of its 12x150mm kii shielded bladed access systems. this is due to a potential for the blade to remain exposed after shield deployment. further use of any affected product should cease immediately. the affected model number is ctb71, and the affected lot is 1179107.
  • Acción
    Applied Medical sent an Urgent Medical Device Recall to all affected customers in November 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indcated any product their facility is returning. The Recall confirmation form should be returned to Applied Medical by emailing to recall60494844#applied medical.com or fax to 949-713-8832. Return affecte4d product and a copy of the confirmation form to Applied Medical. Customers with questions were instructed to call 949-713-8662. For questions regarding this recall 949-713-8662.

Device

Device Recall Kii Shielded Bladed Access System
  • Modelo / Serial
    Lot Number: 1179107
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and France.
  • Descripción del producto
    Laparoscope, general; plastic surgery || Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments.
  • Manufacturer
    Applied Medical Resources Corp

Manufacturer

Applied Medical Resources Corp
  • Dirección del fabricante
    Applied Medical Resources Corp, 22872 Avenida Empresa # 3, Rancho Santa Margarita CA 92688-2650
  • Empresa matriz del fabricante (2017)
    Applied Medical Corporation
  • Source
    USFDA