Events

Retiro De Equipo (Recall) de Ethicon Harmonic Ace+ 7 Laparoscopic Shears

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Ethicon Endo-Surgery LLC.

¿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
    19243
  • Fecha de inicio del evento
    2015-10-07
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    Ethicon, inc. have determined that under extreme handling circumstances, damage, such as a hole, can occur in the tyvek® lid due to an interaction between the advanced haemostasis (green) button and the tyvek® lid which could compromise device sterility. ethicon has received no reports of adverse events for this issue.
  • Acción
    Product to be returned to supplier

Device

Ethicon Harmonic Ace+ 7 Laparoscopic Shears
  • Modelo / Serial
    Model: HARH23, HARH231, HARH36, HARH361, HARH45 and HARH451, Affected: Expiration dates prior to 2020-08
  • Manufacturer
    Ethicon Endo-Surgery LLC

Manufacturer

Ethicon Endo-Surgery LLC