Retiro De Equipo (Recall) de Atrium Chest DrainsOcean Drains

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet Australia Pty Ltd.

¿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 II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Atrium chest drainage products are packaged with a double sequential sterile wrap and placed into an outer dust cover. the dust cover is folded over and 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; the outer dust cover is not sterile. the two sterilisation wraps are what provide the sterile barrier for the product. this packaging system is the same configuration used on atrium chest drainage products for the past 30 years. maquet is providing users with clarification as to which part of the packaged drain is sterile. in addition, maquet is advising that product manufactured after october 18 2016 will contain a new warning label that identifies the pouch as not being a sterile barrier and warns the user that only the chest drain can be entered into the sterile field.
  • Acción
    Maquet is informing users of the following steps for introduction of the Atrium Chest Drains into the sterile field; To introduce the chest drain into the sterile field: 1. Remove the wrapped chest drain from the dust cover. 2. Open the 2 sterilisation wraps using sterile technique. 3. Only enter the chest drain into the sterile field. Maquet is also providing the new warning label that product manufactured from October 18 2016 will contain, and is requesting users to post copies of this label near all Atrium chest drain product inventory with expiration date prior to October 2019. This action has been closed-out on 26/05/2017.


  • Modelo / Serial
    Atrium Chest DrainsOcean DrainsModel Numbers: 2002-300, 2012-320, 2050-300Oasis DrainsModel Numbers: 3600-100, 3612-100, 3612-100, 3620-100Express DrainsModel Numbers: 4000-100N, 40120-100NExpress MiniModel Number: 16400All Lot Numbers with Expiration Date Prior to October 2019ARTG Number: 119726
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source