Events

Retiro De Equipo (Recall) de STATLOCK - IV

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
    153492
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-09-07
  • 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
    Bard is informing customers of a label change to a component in the listed bard access systems (bas) trays and/or kits. the component skin prep pad (part number p-1010) manufactured by aplicare inc. will no longer be labeled as sterile (new non-sterile part number p-1030). over the next several months bas will deplete inventory of the sterile-labeled product and transition to the modified labeled product in its trays and/or kits. no product return is required.

Device

STATLOCK - IV
  • Modelo / Serial
    Model Catalog: VITML6AV (Lot serial: ALL); Model Catalog: 1173118 (Lot serial: ALL); Model Catalog: VIDTML4 (Lot serial: ALL); Model Catalog: VIDML6 (Lot serial: ALL); Model Catalog: VIDML12 (Lot serial: ALL); Model Catalog: IV0572 (Lot serial: ALL); Model Catalog: IV0571 (Lot serial: ALL); Model Catalog: IV0564 (Lot serial: ALL); Model Catalog: IV0541 (Lot serial: ALL); Model Catalog: IV0525 (Lot serial: ALL); Model Catalog: 3194155 (Lot serial: ALL); Model Catalog: 3194135 (Lot serial: ALL); Model Catalog: 9386118Q (Lot serial: ALL); Model Catalog: 3386118Q (Lot serial: ALL); Model Catalog: 3396355 (Lot serial: ALL); Model Catalog: 3396335 (Lot serial: ALL); Model Catalog: 3395335Q (Lot serial: ALL); Model Catalog: 3395355Q (Lot serial: ALL); Model Catalog: 9396118 (Lot serial: ALL); Model Catalog: 9395118Q (Lot serial: ALL); Model Catalog: 9295118 (Lot serial: ALL); Model Catalog: 9194118 (Lot serial: ALL); Model Catalog: 1386118 (Lot serial: ALL); Model Catalog: 1385118Q (Lot serial: ALL); Model Catalog:
  • Descripción del producto
    STATLOCK - IV;POWERPICC SV CATHETER W/SHERLOCK 3CG TPS STYLET BASIC TRAY;POWERPICC SOLO CATHETER SL SS GUIDEWIRE;POWERPICC CATHETER SHORT TAPER SHERLOCK TLS;POWERPICC CATHETER SHORT TAPER MICROEZ;POWERPICC SOLO CATHETER TL NITINOL GUIDEWIRE;POWERPICC SOLO
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.