Events

Rappel de TRUGUIDE COAXIAL BIOPSY NEEDLE

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
    16366
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-04-01
  • 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
    Black circle on pouch label for c2013b stated "for use with bard maxcore or monopty instruments" instead of "for use with magnum instruments & biopsy needles or biopty instrument & biopty-cut needles".

Device

TRUGUIDE COAXIAL BIOPSY NEEDLE
  • Modèle / numéro de série
    Model Catalog: C2020B (Lot serial: MANUFACTURER); Model Catalog: C2016B (Lot serial: MANUFACTURER); Model Catalog: C1410A (Lot serial: >10 NUMBERS); Model Catalog: C2013B (Lot serial: MANUFACTURER); Model Catalog: C1820B (Lot serial: MANUFACTURER); Model Catalog: C1816B (Lot serial: MANUFACTURER); Model Catalog: C1813B (Lot serial: MANUFACTURER); Model Catalog: C1810B (Lot serial: MANUFACTURER); Model Catalog: C1410A (Lot serial: MANUFACTURER); Model Catalog: C2020B (Lot serial: CONTACT); Model Catalog: C2016B (Lot serial: CONTACT); Model Catalog: C2013B (Lot serial: CONTACT); Model Catalog: C1820B (Lot serial: CONTACT); Model Catalog: C1816B (Lot serial: CONTACT); Model Catalog: C1813B (Lot serial: CONTACT); Model Catalog: C1810B (Lot serial: CONTACT); Model Catalog: C1410A (Lot serial: CONTACT); Model Catalog: C2020B (Lot serial: >10 NUMBERS); Model Catalog: C2016B (Lot serial: >10 NUMBERS); Model Catalog: C2013B (Lot serial: >10 NUMBERS); Model Catalog: C1820B (Lot serial: >10 NUMBERS); Model Catalog: C18
  • Description du dispositif
    TRUGUIDE COAXIAL BIOPSY NEEDLE
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.