Events

Retiro De Equipo (Recall) de Stryker Strykflow Suction Irrigation Tips

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 Stryker Endoscopy.

¿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
    14462
  • Fecha de inicio del evento
    2013-04-08
  • 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: Stryker New Zealand Ltd, 515 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer has discovered that the temperatures listed for the pre-vacuum steam sterilization (wrapped method) did not match the validated temperatures for six out of the eleven languages. the pre-vacuum steam sterilization temperature in the instructions for use (ifu rev. k) incorrectly listed 121 - 123°c, instead of the correct 132 - 133°c.
  • Acción
    Instructions for use to be updated

Device

Stryker Strykflow Suction Irrigation Tips
  • Modelo / Serial
    Model: Catalogue: 250070403, 250070404, 250070407, 250070408, 250070409, 250070437, 250070483, 250070484, 250070487, 250070488, 250070489, 250070490, Affected: Selected lot numbers
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    NZMMDSA