Events

Retiro De Equipo (Recall) de Arrow Multi-Lumen Central Venous Catheters

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 Arrow International Inc.

¿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
    16809
  • Fecha de inicio del evento
    2014-07-07
  • 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
    Arrow international, inc. ("arrow") is notifying customers that there is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvcs). as an example, the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. the misprint does not impact the use of the product including use of individual lumens for infusion, blood draws, etc. the colour coding of all hubs is correct and corresponds to the arrow system: white = proximal lumen; grey = medial lumen 1; blue = medial lumen 2; brown = distal lumen.
  • Acción
    Manufacturer to issue advice regarding use

Device

Arrow Multi-Lumen Central Venous Catheters
  • Modelo / Serial
    Model: Models: CS-22854-E, CS-12854-E, CS-15854-E, CS-25854-E,CS-42854-E,ASK-22854-IM, Affected: Various
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc