Events

Rappel de RING AND TANDEM COMBO KIT

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
    82186
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2012-10-01
  • 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
    An anomaly has been identified with the al07289000 rectal retractor stainless steel. the rectal retractors have shown evidence that contaminates or fluids may enter into the center of the rectal retractor paddle through the cross pins or bottom rod areas. the rectal retractor instruments have been identified to potentially have contaminating materials present after clinical use that cannot be removed by the instructed cleaning disinfecting and sterilization method. at this time it appears that the design of the paddle component is allowing for ingress and retention of bodily fluids or cleaning reagents during their clinical use and during their reprocessing for re-use. this issue is an internal finding - therefore no misadministration or serious deterioration in the state of health was reported. there have been no reports of this issue that have occurred in canada or within the eea member states.

Device

RING AND TANDEM COMBO KIT
  • Modèle / numéro de série
    Model Catalog: AL13016002 (Lot serial: H600346); Model Catalog: AL13015000 (Lot serial: H600346); Model Catalog: AL13016000 (Lot serial: H600346); Model Catalog: AL13016001 (Lot serial: H600346)
  • Description du dispositif
    Ring and Tandem Combo Kit
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.