Events

Retiro De Equipo (Recall) de Peters Surgical Cardioxyl Sutures

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 Peters Surgical.

¿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
    16859
  • Fecha de inicio del evento
    2014-06-19
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified. this treatment substance aims at easing the crimping process of our needles. this treatment is only applied on the area where the thread is in contact with the needle: meaning on 1(one) centimetre from the end of the thread approximately. the treated ends are clearly out of the implanted section of the thread.
  • Acción
    Product to be returned to supplier

Device

Peters Surgical Cardioxyl Sutures
  • Modelo / Serial
    Model: Catalogue Numbers: 73I30AZ, 73P30U, 73S30AY, Affected: Lots: 967180; 957090 & 04168; 909630 respectively
  • Manufacturer
    Peters Surgical

Manufacturer

Peters Surgical
  • Empresa matriz del fabricante (2017)
    Eurazeo SA
  • Source
    NZMMDSA