Events

Retiro De Equipo (Recall) de Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades

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 Verathon Medical (Canada) ULC.

¿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
    18653
  • Fecha de inicio del evento
    2015-06-18
  • 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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
  • Causa
    Verathon, manufacturer of glidescope video laryngoscopes, is revising the operations and maintenance manuals (omm) for certain glidescope gvl and avl reusable laryngoscope blades. the new omms specifically state compatibility limitations of the reusable video laryngoscope validated through simulated use cycles, using certain cleaning and disinfection agents. also, for the purpose of cleaning/disinfecting reusable blades, the following chemicals have been removed from the omms:, · bleach (sodium hypochlorite), · isopropyl alcohol solution, · liquid hydrogen peroxide (7.5%).
  • Acción
    Instructions for use to be updated

Device

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades
  • Modelo / Serial
    Model: Models: GVL3, GVL4, GVL5, AVL2, AVL3, AVL4, AVL5, Affected: Selected serial number ranges
  • Manufacturer
    Verathon Medical (Canada) ULC

Manufacturer

Verathon Medical (Canada) ULC