Events

Retiro De Equipo (Recall) de Applied Medical Inzii Tissue Retrieval Bag, 12/15mm

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 Applied Medical Resources Corporation.

¿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
    15561
  • Fecha de inicio del evento
    2013-10-23
  • 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: Applied Medical New Zealand Ltd, 6/56 Pavilion Drive, Mangere, Auckland 2022
  • Causa
    During shipment, the retrieval system packaging has the potential to become punctured with small holes, which could compromise the sterile barrier. the likelihood of this situation to occur and result in patient harm is highly unlikely.
  • Acción
    Product to be returned to supplier

Device

Applied Medical Inzii Tissue Retrieval Bag, 12/15mm

Manufacturer

Applied Medical Resources Corporation