Events

Retiro De Equipo (Recall) de Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Merck 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-00768-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-10
  • 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-00768-1
  • 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
    Merck has received a product complaint regarding concerns of colour indications on packaging being insufficiently clear and the possibility of end users confusing the colour coding in the explanatory box with the corresponding colour on the ph strip. please note that with these ph indicator papers, the printed scale on the packaging serves purely as an instruction on how to use the product. the ph is only identified by comparison of the test square with the printed colours on the test strip itself.
  • Acción
    Merck is advising users to inspect stock and remove any remaining strips of the affected lots from use. Affected stock will be replaced with a revised indicator strip or a credit note issued. This action has been closed-out on 20/02/2017.

Device

Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tub...
  • Modelo / Serial
    Maxter Catheters Entral pH Indicator Strips (used to determine the pH of the stomach prior to tube feeding)Catalogue number: IN01Order code: NAAUIN01Lot Numbers: 509029, 604025ARTG number: 260068
  • Manufacturer
    Merck Pty Ltd

Manufacturer

Merck Pty Ltd
  • Empresa matriz del fabricante (2017)
    Merck KGaA
  • Source
    DHTGA