Events

Retiro De Equipo (Recall) de Teleflex Medical RTP - Valve, non-rebreathing

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 Teleflex Medical Inc.

¿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
    22833
  • Fecha de inicio del evento
    2018-04-19
  • 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
    The manufacturer has indentified that the hudson rci one-way valve with capped may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient. disconnection of the valve is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the valve is connected. however, disconnection of the valve in ventilator dependent patients without prompt response could lead to hypoxia, organ failure, or death.
  • Acción
    Product to be returned to supplier

Device

Teleflex Medical RTP - Valve, non-rebreathing
  • Modelo / Serial
    Model: , Affected: Affected lot numbers 74D1501706, 74K1502092, 74F1600367, 74J1600117, 74L1601916, 74C1701733, 74F1700707, 74D1501731, 74K1502045, 74F1601072, 74J1601101, 74M1600284, 74C1702365, 74F1701866
  • Manufacturer
    Teleflex Medical Inc

Manufacturer

Teleflex Medical Inc