Events

Retiro De Equipo (Recall) de Molnlycke Surgical ProcedurePak

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 Molnlycke Health Care AB.

¿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
    15533
  • Fecha de inicio del evento
    2013-10-21
  • 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: Molnlycke Health Care Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Manukau 2022
  • Causa
    The manufacturer has determined that some units of the basin liners provided in the pack, have small holes in them which could be undetectable in normal use. although the instructions for use of the basin liner itself clearly state that it should not be used to hold fluids or material for invasive use, these holes could, if present potentially compromise the sterile field.
  • Acción
    Manufacturer to issue advice regarding use

Device

Molnlycke Surgical ProcedurePak
  • Modelo / Serial
    Model: Codes: 97020182-01, 97020184-01, 97020185-02, 97044862-01, 97044864-02, Affected: Various lots
  • Manufacturer
    Molnlycke Health Care AB

Manufacturer

Molnlycke Health Care AB
  • Empresa matriz del fabricante (2017)
    Investor AB
  • Source
    NZMMDSA