Events

Retiro De Equipo (Recall) de LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

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-2015-RN-01089-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-09
  • 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-2015-RN-01089-1
  • 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
    Lemaitre embolectomy catheters are indicated for the removal of arterial emboli and thrombi. a small number of these products from the affected lot may have a compromised sterile barrier due to a packaging tube defect in the form of a pinhole at the sealed end of the packaging tube. the current ifu does not require inspection of the packaging prior to use and loss of product sterility could not be visually identified. the issue occurred due to fluctuations in the power sources for the sealing machine during the packaging tube manufacturing process.Loss of product sterility could lead to cross-contamination and infection.No complaints have been received relating to this issue.
  • Acción
    Users are asked to inspect their stock and quarantine all affected units prior to their return to Emergo as per the instructions in the Customer Letter. This action has been closed-out on 18/08/2016.

Device

LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia