Events

Retiro De Equipo (Recall) de LIFESTYLES SKYN ELITE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ANSELL HEALTHCARE PRODUCTS LLC.

¿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
    44418
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-08-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    On august 21 ansell healthcare products llc was advised that a retail customer had received the referenced product with english only (us) package labeling. the customer also received english/french (canada) packages as well. the english only packaging was us market product labeling and not the carton labeling specific to canada. the us package labeling is in english does not contain french labeling and does contain all required label elements required under iso 4074 - natural rubber latex male condoms - requirement and test methods. this standard to which ansell attested compliance to under the original license outlines the requirements for labeling.

Device

LIFESTYLES SKYN ELITE
  • Modelo / Serial
    Model Catalog: 7210 (Lot serial: 170719071C)
  • Descripción del producto
    LIFESTYLES SKYN ELITE
  • Manufacturer
    ANSELL HEALTHCARE PRODUCTS LLC

Manufacturer

ANSELL HEALTHCARE PRODUCTS LLC
  • Dirección del fabricante
    DOTHAN
  • Empresa matriz del fabricante (2017)
    Ansell Ltd.
  • Source
    HC