Events

Retiro De Equipo (Recall) de American Surgical Sponges/15252/sponges

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 American Surgical Sponges.

¿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
    20013
  • Fecha de inicio del evento
    2016-04-12
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    A failure in the sterile peel pouch has been discovered during a quality control inspection. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. after the failure was identified, a comprehensive investigation has shown an occurrence rate of less than 0.01% for the affected lots., the customer was credited & the supplier agreed to have the product destroyed off site.
  • Acción
    Product to be destroyed

Device

American Surgical Sponges/15252/sponges
  • Modelo / Serial
    Model: AS-30-00, AS-30-02, AS-30-03, AS-30-04, AS-30-07 and AS-63-01, Affected:
  • Manufacturer
    American Surgical Sponges

Manufacturer

American Surgical Sponges