Events

Rappel de WHISTLE TIP CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TELEFLEX MEDICAL 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
    47695
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-09-15
  • 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
    Although the product labeling identifies the catheters as "soft rubber" the natural rubber latex caution statement ("caution: this product contains natural rubber latex which may cause allergic reactions") was not printed on the product label. if a person with a latex sensitivity comes into contact with the latex component of the product an allergic reaction could occur.

Device

WHISTLE TIP CATHETER
  • Modèle / numéro de série
    Model Catalog: 403900120 (Lot serial: 13261); Model Catalog: 403900100 (Lot serial: 13451); Model Catalog: 403900120 (Lot serial: 13451); Model Catalog: 403900100 (Lot serial: 13511); Model Catalog: 403900120 (Lot serial: 13511); Model Catalog: 403900100 (Lot serial: 13261); Model Catalog: 403340140 (Lot serial: 14131); Model Catalog: 403300100 (Lot serial: 13311); Model Catalog: 403300100 (Lot serial: 14131); Model Catalog: 403340140 (Lot serial: 14091); Model Catalog: 403300140 (Lot serial: 14091); Model Catalog: 403300100 (Lot serial: 14091); Model Catalog: 403340140 (Lot serial: 14041); Model Catalog: 403300140 (Lot serial: 14041); Model Catalog: 403300100 (Lot serial: 14041); Model Catalog: 403340140 (Lot serial: 13481); Model Catalog: 403300140 (Lot serial: 13481); Model Catalog: 403300100 (Lot serial: 13481); Model Catalog: 403340140 (Lot serial: 13461); Model Catalog: 403300140 (Lot serial: 13461); Model Catalog: 403300100 (Lot serial: 13461); Model Catalog: 403340140 (Lot serial: 13311); Model Catal
  • Description du dispositif
    NELATON WHISTLE TIP CATHETER
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.