Events

Retiro De Equipo (Recall) de TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ICU MEDICAL 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
    149406
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-09-30
  • 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 medical inc. has identified a potential leak with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or potentially introduce a small amounts of air into the line.

Device

TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH
  • Modelo / Serial
    Model Catalog: 42587-05 (Lot serial: 3247898); Model Catalog: 42590-05 (Lot serial: 3247898); Model Catalog: 42587-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3261651); Model Catalog: 42590-05 (Lot serial: 3292882); Model Catalog: 42587-05 (Lot serial: 3292882); Model Catalog: 011-46104-41 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42583-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42584-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42585-05 (Lot serial: >10 numbers contact mfg.); Model Catalog: 011-46101-92 (Lot serial: >10 numbers contact mfg.); Model Catalog: 42582-06 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3257008); Model Catalog: 42582-06 (Lot serial: 3257008); Model Catalog: 46107-53 (Lot serial: 3264160); Model Catalog: 46107-53 (Lot serial: 3264105); Model Catalog: 42594-05 (Lot serial: 3265442); Model Catalog: 42582-06 (Lot serial: 3264105); Model Catalog: 42641-06 (Lot serial: 3249806)
  • Descripción del producto
    TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH INTRAFLO FLUSH;TRANSPAC DISPOSABLE TRANSDUCER MONITORING KIT WITH 3 ML SQUEEZE FLUSH DEVICE;TRANSPAC IV DISPOSABLE TRANSDUCER WITH STOPCOCKS;TRANSPAC IV MONITORING KIT W/4 WAY STOPCOCK 3 WAY STOPCOCK AND
  • Manufacturer
    ICU MEDICAL INC.

Manufacturer

ICU MEDICAL INC.
  • Dirección del fabricante
    SAN CLEMENTE
  • Empresa matriz del fabricante (2017)
    ICU Medical, Inc.
  • Source
    HC