Events

Retiro De Equipo (Recall) de ORBIT 90 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
    105538
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2011-02-16
  • 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
    All lots of triad alcohol prep pads co-packaged and distributed with icu medical orbit 90 infusion sets and orbit micro infusion sets are being recalled because of concerns about potential contamination of the triad group's product with the bacteria bacillus cereus. the infusion sets are not contaminated and may continue to be used safely.

Device

ORBIT 90 SUBCUTANEOUS INFUSION SET
  • Modelo / Serial
    10 contact mfg"); Model Catalog: M4261 M4291 P1861 P1891 (Lot serial: ">10 contact mfg"); Model Catalog: P2461 P2491 P3061 P3091 (Lot serial: ">10 contact mfg"); Model Catalog: P4261 P4291 (Lot serial: ">10 contact mfg"); Model Catalog: P3051 P3081 P4251 P4281 (Lot serial: ">10 contact mfg"); Model Catalog: P1851 P1881 P2451 P2481 (Lot serial: ">10 contact mfg")" v-b-tooltip> Model Catalog: M1861 M2461 M2491 M3091 (Lot serial: ">10 contact mfg"); Model Catalog: M4261 M4291 P1861 P1891 (Lot serial: ">10 contact mfg"); Model Catalog: P2461 P2491 P3061 P3091 (Lot serial: ">10 contact mfg"); Model Catalog: P4261 P4291 (Lot serial: ">10 contact mfg"); Model Catalog: P3051 P3081 P4251 P4281 (Lot serial: ">10 contact mfg"); Model Catalog: P1851 P1881 P2451 P2481 (Lot serial: ">10 contact mfg")
  • Descripción del producto
    ORBIT 90 SUBCUTANEOUS INFUSION SET
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

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