Events

Retiro De Equipo (Recall) de Cook Inc (Urology) Holmium Laser Fibres (Multi Use) (HLF-M)

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 Cook Incorporated.

¿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
    21403
  • Fecha de inicio del evento
    2017-05-05
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    The manfacturer has identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. the manufacturer preliminary investigation indicates that the validation data related to the reprocessing of these devices do not meet the current guidance.
  • Acción
    Product to be returned to supplier

Device

Cook Inc (Urology) Holmium Laser Fibres (Multi Use) (HLF-M)
  • Modelo / Serial
    Model: , Affected: Catalogue number G48611 HLF-M273-CN, G48613 HLF-M365-CNV, G48615 HLF-M550-CNV All Lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated