Events

Retiro De Equipo (Recall) de ORBIT MICRO SUBCUTANEOUS INFUSION SET

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por INSULINPUMPS.CA 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
    39245
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-04-18
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Icu reported that certain lots of orbit 90 and orbit micro infusion sets may incur damage due to movement during shipping resulting in bent needles. the damage is easily detectible within the unopened sterile tray. if the needle cover is not attached to the needle and/or the needle is bent the device is damaged and should not be used.

Device

ORBIT MICRO SUBCUTANEOUS INFUSION SET
  • Modelo / Serial
    Model Catalog: P2451 (Lot serial: >10 Lot Numbers.); Model Catalog: P4251 (Lot serial: >10 Lot Numbers.); Model Catalog: P3051 (Lot serial: >10 Lot Numbers.); Model Catalog: P4291 (Lot serial: Contact manufacturer.); Model Catalog: P4261 (Lot serial: Contact manufacturer.); Model Catalog: P3091 (Lot serial: Contact manufacturer.); Model Catalog: P3061 (Lot serial: Contact manufacturer.); Model Catalog: P2491 (Lot serial: Contact manufacturer.); Model Catalog: P2461 (Lot serial: Contact manufacturer.); Model Catalog: P1891 (Lot serial: Contact manufacturer.); Model Catalog: P1861 (Lot serial: Contact manufacturer.); Model Catalog: M4291 (Lot serial: Contact manufacturer.); Model Catalog: M4261 (Lot serial: Contact manufacturer.); Model Catalog: M3091 (Lot serial: Contact manufacturer.); Model Catalog: M2491 (Lot serial: Contact manufacturer.); Model Catalog: M2461 (Lot serial: Contact manufacturer.); Model Catalog: M1861 (Lot serial: Contact manufacturer.); Model Catalog: P4291 (Lot serial: >10 lot numbers.);
  • Descripción del producto
    ORBIT MICRO SUBCUTANEOUS INFUSION SET
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

INSULINPUMPS.CA INC.
  • Dirección del fabricante
    OAKVILLE
  • Source
    HC