Retiro De Equipo (Recall) de Device Recall Kii Shielded Bladed Access System and Kii Low Profile 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
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Causa
    Due to possibility of insufficient sterilization.
  • Acción
    An Urgent Medical Device Recall letter dated 5/4/17 was sent to customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of Kii trocar models, CTB14 Kii 5x55mm Shielded Bladed Z-Thread Dual Pack and CTB23 Kii 5x55mm Low Profile Bladed Z-Thread Dual Pack, due to the possibility of insufficient sterilization. Customers are instructed to complete the attached recall notification confirmation form to acknowledge the recall and indicate if their facility is returning or already used the lots on recall. Customers are instructed to return the Recall Notification Confirmation Form to Applied Medical by emailing to or faxing to 949-713-8847. The recall letter instructs the customers that for product return questions to contact Karen Mitchell, Associate Manager Sales Operations, RGA Dept. at (949) 713-8622 or by email at For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or by email at On 8/21/17 an Urgent Medical Device recall letter was sent to their customers to inform them that Applied Medical is conducting a voluntary recall of specific lots of the Kii trocar model, CTR14 Kii 5x55mm Optical Z-Thread Dual Pack. During shipment, the trocar packaging has the potential to become punctured with small holes, which would compromise the sterile barrier.


  • Modelo / Serial
    CTB14 (lots 1275207, 1279542, 1283892 and 1288910) CTB23 (lots 1269692, 1271037, 1282163 and 1288759) CTR14 (lots 1269694, 1275188, 1279039, 1283226, and 1287785)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US and worldwide: Australia, Finland, France, United Kingdom
  • Descripción del producto
    Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and || Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
  • Manufacturer


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