Events

Retiro De Equipo (Recall) de Medi-vac Flex Advantage Suction Liners and Canisters

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 Cardinal Health.

¿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
    13621
  • Fecha de inicio del evento
    2012-10-24
  • 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: Medline International New Zealand Limited, 14 George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    Safety alert notice advising customers that some users of the product:, 1. may be testing functionality by "bumping" the medi-vac liners. as indicated in the warning section of the product's dfu, premature shut-off of the vacuum may occur if the canister is bumped., 2. may be testing vacuum/ suction by occluding the medi-vac liner's patient port with their finger. this practice may activate the mechanical shut-off and consequently turn offf the vacuum. occlusion of the patient port as a testing method is not included in the product's dfu and therefore is not a recommended test.
  • Acción
    Manufacturer to issue advice regarding use

Device

Medi-vac Flex Advantage Suction Liners and Canisters
  • Modelo / Serial
    Model: 65652-6ll, 65652-616, 65652-631, 65651-910C, 65651-920C and 65651-930C, Affected: All lots
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health