Events

Retiro De Equipo (Recall) de Resus-EZY Air Cushion Mask

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Schell Medical Corporation 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
    Recall
  • ID del evento
    RC-2016-RN-01169-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-09-07
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01169-1
  • 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
    Schell medical is advising users of an issue regarding product expiry dates for air cushion masks that were purchased between july 2009 and july 2011. these older masks do not have the expiry date shown on the unit label. they do have a lot number, which also doubles as the manufacturing date. this date is shown in the ddmmyy format, e.G lot no. 240511 indicates the mask was manufactured on 24th may 2011. the life of the mask is 5 years, thus in this example this mask has expired and should be discarded.
  • Acción
    Schell Medical is advising users to inspect stock and discard any remaining units of the affected lots. Product manufactured since July 2011 includes the expiry date on the label and is unaffected by this issue. This action has been closed-out on 12/05/2017.

Device

Resus-EZY Air Cushion Mask
  • Modelo / Serial
    Resus-EZY Air Cushion MaskCatalogue Number: HP-8400, HP-8401, HP-8402, HP-8403, HP-8404, HP-84505Multiple lot numbers affectedSupplied between July 2009 and July 2011ARTG Number: 143640
  • Manufacturer
    Schell Medical Corporation Pty Ltd

Manufacturer

Schell Medical Corporation Pty Ltd