Events

Retiro De Equipo (Recall) de BARD URINE METER FOLEY TRAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BARD CANADA 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
    52290
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-09-19
  • 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
    Contained within certain medical device kits manufactured by c.R. bard inc is a bard statlock stabilization device sub-assembly which includes a skin protectant prep pad component that is manufactured by aplicare inc. aplicare is changing its labeling to no longer identify the prep pad as sterile. however bard trays containing the prep pad indicate that components within the kit packaging are sterile. the recall will inform bard customers of the conflict between bard's and aplicare's labels. no product return is required.

Device

BARD URINE METER FOLEY TRAY
  • Modelo / Serial
    Model Catalog: A902914 (Lot serial: ALL); Model Catalog: A902418 (Lot serial: ALL); Model Catalog: A902416 (Lot serial: ALL); Model Catalog: A800366 (Lot serial: ALL); Model Catalog: A800365 (Lot serial: ALL); Model Catalog: A800364 (Lot serial: ALL); Model Catalog: A902918 (Lot serial: ALL); Model Catalog: A902916 (Lot serial: ALL); Model Catalog: A902414 (Lot serial: ALL); Model Catalog: A119418M (Lot serial: ALL); Model Catalog: A119416M (Lot serial: ALL); Model Catalog: A897514 (Lot serial: ALL); Model Catalog: A897516 (Lot serial: ALL); Model Catalog: A897518 (Lot serial: ALL); Model Catalog: A303418A (Lot serial: ALL); Model Catalog: A303416A (Lot serial: ALL); Model Catalog: NG0100 (Lot serial: ALL); Model Catalog: A303414A (Lot serial: ALL); Model Catalog: 303118A (Lot serial: ALL); Model Catalog: 303116A (Lot serial: ALL); Model Catalog: 399100A (Lot serial: ALL); Model Catalog: 304100A (Lot serial: ALL); Model Catalog: A319518AM (Lot serial: ALL); Model Catalog: A319516AM (Lot serial: ALL); Model C
  • Descripción del producto
    BARD URINE METER FOLEY TRAY;BARDEX LUBRICATH TEMPERATURE SENSING FOLEY TRAY W/BARD HYDROGEL;DRAINAGE BAG FOLEY TRAY W/ANTI-REFLUX CHAMBER;LUBRI-SIL COMPLETE CARE STATLOCK URINE METER FOLEY TRAY;STATLOCK NASOGASTRIC STABILIZATION DEVICE;INFECTION CONTROL A
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.