Events

Retiro De Equipo (Recall) de EZ-Strip 145ìm (Assisted reproduction microtool)

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

¿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-01286-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-04
  • 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-01286-1
  • 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
    It has been reported that an ez-strip product from the stated lot may contain debris that could result in the device failing to perform its intended purpose. this fault, if not identified by the customer could result in the loss of oocytes.
  • Acción
    Key IVF Supplies are advising customers to cease use of the affected lot and immediately quarantine all remaining packs. Key IVF will arrange for the collection of the quarantined packs and will replace affected stock. This action has been closed-out on 02/03/2017.

Device

EZ-Strip 145ìm (Assisted reproduction microtool)
  • Modelo / Serial
    EZ-Strip 145ìm (Assisted reproduction microtool) Part Number: 7-72-1145/20Lot Number: 150299-01Expiry Date: June 2018
  • Manufacturer
    Key IVF Supplies

Manufacturer

Key IVF Supplies