Events

Retiro De Equipo (Recall) de OASIS CHEST DRAIN

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ATRIUM MEDICAL CORPORATION.

¿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
    68508
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-12-09
  • 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
    To provide clarification about the packaging configuration of the products. products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is secured with the package label. the label on the outer package denotes the product as being sterile. the chest drain inside the packaging is sterile but the outer dust cover is not sterile.

Device

OASIS CHEST DRAIN
  • Modelo / Serial
    Model Catalog: 3600-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2012-320 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-400 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-300 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-000 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 4020-100N (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 4000-100N (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 16400 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3612-400 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3650-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3620-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 3612-100 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2050-000 (Lot serial: Lots expiring before Oct. 2019); Model Catalog: 2002-100 (Lot serial: Lots expiring before Oct. 2019)
  • Descripción del producto
    Oasis Chest Drain;Ocean Chest Drain;Express Chest Drain;Express Mini 500 Chest Drain
  • Manufacturer
    ATRIUM MEDICAL CORPORATION

Manufacturer

ATRIUM MEDICAL CORPORATION
  • Dirección del fabricante
    HUDSON
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC