Events

Retiro De Equipo (Recall) de Intelligent Reload

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 Surgical Devices/Covidien.

¿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
    53694
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0405-2010
  • Fecha de inicio del evento
    2009-09-23
  • Fecha de publicación del evento
    2009-11-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86361
  • 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
    Implantable staple. - Product Code GDW
  • Causa
    Lack of assurance that products were manufactured under gmps. this action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.
  • Acción
    The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.

Device

Intelligent Reload
  • Modelo / Serial
    all codes
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Portugal, India, Austria, Turkey, and Greece.
  • Descripción del producto
    Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Green, product code iR45MG; Intelligent Reload, 45 mm, Vascular, product code iR45V; Intelligent Reload, 60 mm Blue, product code iR60B; Intelligent Reload, 60 mm Green, product code iR60G; Intelligent Reload Mid Cut 60mm Blue, product code iR60MB; Intelligent Reload Mid Cut 60mm Green, product code iR60MG; Intelligent Reload, 60 mm Blue No Knife, product code iR60B4.
  • Manufacturer
    Surgical Devices/Covidien

Manufacturer

Surgical Devices/Covidien
  • Dirección del fabricante
    Surgical Devices/Covidien, 60 Middletown Ave, North Haven CT 06473-3908
  • Source
    USFDA