Events

Retiro De Equipo (Recall) de AnastoClip AC Closure System

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

¿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-2017-RN-00145-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-02-03
  • 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-2017-RN-00145-1
  • 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
    The manufacturer, lemaitre vascular has identified that the box labels for certain lots of catalogue numbers 4012-02 and 4012-03 have an incorrect dimension listed. the box label for each size device illustrates a clip gap that is smaller by 0.3mm – 0.5mm than the actual clip of each size product. the ifu and tyvek labels for the product have the correct size of the clip gap noted for each size. there have been no complaints about this issue.
  • Acción
    Emergo is advising customers that all affected product should be returned for replacement. This action has been closed-out on 06/07/2017.

Device

AnastoClip AC Closure System
  • Modelo / Serial
    AnastoClip AC Closure SystemCatalogue Number: 4012-02 Lot Numbers: EAV1023 (Expiry Dec. 2020), EAV1032 (Expiry Sept. 2021)Catalogue Number: 4012-03Lot Number: EAV1016 (Expiry 28 Oct. 2020)ARTG Number: 120976
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia