Events

Retiro De Equipo (Recall) de Laerdal Suction Unit (78xxxx)

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 Laerdal Medical AS.

¿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
    20703
  • Fecha de inicio del evento
    2016-10-10
  • 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: Laerdal (New Zealand) Ltd, Unit O, Cain Commerical Centre, 20 Cain Road, Penrose
  • Causa
    This is a follow-up to the initial communication, to provide information on a long-term solution, with regards to the laerdal suction unit (lsu) when used with the lsu nimh battery that has been stored or installed at low temperatures for a prolonged period.
  • Acción
    Instructions for use to be updated

Device

Laerdal Suction Unit (78xxxx)
  • Modelo / Serial
    Model: , Affected: 7800033 LSU WITH RESUABLE CANISTER WITH NIMH BATTERY, 78001033 WITH ABBOT RECEPTAL CANISTER WITH NIMH BATTERY, 78002033 LSU WITH BEMIS CANISTER WITH NIMH BATTERY, 78003033 WITH SERRES SUCTION BAG CANISTER SYSTEM WITH NIMH BATTERY
  • Manufacturer
    Laerdal Medical AS

Manufacturer

Laerdal Medical AS