Events

Retiro De Equipo (Recall) de Sterilisation Process Indicators - Enzymatic/ chemical

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 3M Health Care Group.

¿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
    21424
  • Fecha de inicio del evento
    2017-05-15
  • 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: 3M New Zealand Ltd, 250 Archers Road, Glenfield, AUCKLAND 0627
  • Causa
    The manufacturer has confirmed that some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. if the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process.
  • Acción
    Product to be exchanged

Device

Sterilisation Process Indicators - Enzymatic/ chemical
  • Modelo / Serial
    Model: , Affected: Roll Size 1322-24MM, Lot 2018-04RA, 2018-05RB, 2018-06RC, 2018-06RD. Roll Size 1355-18MM, Lot 2018-04RA, 2018-05RB, 2018-06RD. Roll Size 1355-24MM, Lot: 2018-04RA, 2018-05RB, 2018-06RD
  • Manufacturer
    3M Health Care Group

Manufacturer

3M Health Care Group
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    NZMMDSA