Retiro De Equipo (Recall) de Device Recall GK213, AME Standard Kit

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Clip, hemostatic - Product Code MCH
  • Causa
    Applied medical resources corporation is recalling ca500 epix universal clip applier, kit models std gk258 ame standard kit 44, std kit gk213, ame standard kit 15, and std kit gk260, standard set 360 z, which contain the affected ca500 lot, because of a potential loading mechanism nonconformance.
  • Acción
    Customer notification letters were sent on December 22, 2015 for the U.S. and on January 6, 2016 for those in Europe. The customer notification letter requested that the following actions be taken: - Check inventory for recalled product. - Complete the attached Recall Notification Confirmation Form to acknowledge the recall, indicate if facility is returning or has already used this lot, and provide a no-charge PO number if replacements requested. - Return the Recall Notification Confirmation Form to Applied Medical by emailing to or faxing to (949) 713-8936. - Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical For product return questions contact Karen Mitchell, Sales Operations Supervisor, RGA Dept. at (949) 713-8622 or by email at For regulatory questions contact Lauren Contursi, at (949) 713-8767 or by email at


  • Modelo / Serial
    Lot #: 1239287
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    U.S .Nationwide Distribution in the states of GA, AL, LA, TX, MN, AK, CA, ID, OR, UT, WY, NM, and AZ. Foreign distirbution to the following; Austria, Belgium, Denmarl, Canada, Japan, France, Germany, Ireland, Italy, Greece, Netherlands, Russia, Spain, Switzerland, Turkey, Great Britain
  • Descripción del producto
    STD KIT GK213, AME Standard Kit 15 || Product Usage: || The Epix disposable laparoscopic clip applier is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.
  • Manufacturer


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