Events

Rappel de STATLOCK - IV

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BARD CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    153492
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-09-07
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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:
  • Description du dispositif
    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.