Events

Retiro De Equipo (Recall) de Infusion - Swiss - Connectors Adaptors

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 CareFusion Switzerland 317 Sarl.

¿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
    22024
  • Fecha de inicio del evento
    2017-09-26
  • 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: CareFusion New Zealand 313 Limited, Unit 14, 13 Highbrook Drive, East Tamaki, AUCKLAND
  • Causa
    The investigation results indicate that the pinholes in the blister pouch is related to the secondary packaging process where the blister packs are placed in dispensers and in shelf boxes. the device has sharp points and during the packing of the carton, accidental pressure was applied, causing the blister pouches to press against each other.
  • Acción
    Product to be returned to supplier

Device

Infusion - Swiss - Connectors Adaptors
  • Modelo / Serial
    Model: , Affected: 11 gauge 9391-0200 Lot numbers 1470303001, 1470304601, 1470306301,1470311301, 1470314801, 1570317701,1570317702, 1570317704, 1570322001,1470306602
  • Manufacturer
    CareFusion Switzerland 317 Sarl

Manufacturer

CareFusion Switzerland 317 Sarl