Events

Rappel de PLASTIC NEEDLE WITH MANDRIN

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par VARIAN MEDICAL SYSTEMS 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
    152416
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-07-29
  • 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
    Previous recall (53838) addressed needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. recall 66002 supplements and modifies previous noticewhere users are instructed to stop using any plastic needles they may have in inventory with lot numbers c01 to d01 and those with lot numbers which start with h or i. this recall also requires users to return any plastic needles with lot numbers c01 to d01 and those lot numbers which start with h or i to varian brachiotherapy for replacement with plastic needles starting with lot j or higher.

Device

PLASTIC NEEDLE WITH MANDRIN
  • Modèle / numéro de série
    Model Catalog: GM11007570 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: Contact manufacturers.); Model Catalog: GM11007570 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: >10 lot numbers.)
  • Description du dispositif
    PLASTIC NEEDLE WITH MANDRIN
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.