Events

Retiro De Equipo (Recall) de Medline Custom Procedure Kits Class 2b

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 Medline Assembly Australia Pty Ltd.

¿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
    21017
  • Fecha de inicio del evento
    2017-01-17
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Causa
    It has been reported that on rare occasions, the devon light glove may split upon application to the devon™ light handle adapter. some of the reported splits resulted from difficult application of the light glove to the handle adapter. more recently, clinicians have reported finding splits in the light glove following surgery completion, when removing glove from packaging.
  • Acción
    Instructions for use to be updated

Device

Medline Custom Procedure Kits Class 2b
  • Modelo / Serial
    Model: , Affected: CS1672744, CS1672725, CS1672725, CS1672725, CS1671553, CS1672725, CS1672725, CS1672750, CS1671552
  • Manufacturer
    Medline Assembly Australia Pty Ltd

Manufacturer

Medline Assembly Australia Pty Ltd