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
    21295
  • Fecha de inicio del evento
    2017-04-10
  • 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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
  • Causa
    The manufacturer has received complaints for peel away sheaths flaring. the instructions for use included in the kits do not inform the user that a skin nick or alternate enlargement method may be required for difficult insertions. the use of a skin nick reduces the probability of sheath flare and subsequent complications.
  • Acción
    Instructions for use to be updated

Device

Arrow International - Peripherally-inserted central venous catheter
  • Modelo / Serial
    Model: , Affected: ARROW PICC Kits with Peel-Away Sheath Component
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc