Events

Retiro De Equipo (Recall) de Arrow International - Peripherally-inserted central venous catheter

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 Arrow International 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
    22938
  • Fecha de inicio del evento
    2018-06-29
  • 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 become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
  • Acción
    Product to be destroyed

Device

Arrow International - Peripherally-inserted central venous catheter

Manufacturer

Arrow International Inc