Rappel de HEMOCLIP PLUS TITANIUM LIGATING CLIPS

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
    78210
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2008-09-03
  • Pays de l'événement
  • 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
    Large holes were detected in the thermoformed tray of certain sterile packaged units meaning the sterile integrity cannot be guaranteed.

Device

  • Modèle / numéro de série
    Model Catalog: 534837 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 001200 (Lot serial: MORE HAN 10 LOT NUMBERS); Model Catalog: 534735 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533872 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533862 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533837 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533802 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533737 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533735 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533702 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 533700 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 004200 (Lot serial: MORE HAN 10 LOT NUMBERS); Model Catalog: 003200 (Lot serial: MORE HAN 10 LOT NUMBERS); Model Catalog: 002200 (Lot serial: MORE HAN 10 LOT NUMBERS); Model Catalog: 001201 (Lot serial: MORE HAN 10 LOT NUMBERS); Model Catalog: 534737 (Lot serial: MORE THAN 10 LOT NUMBERS); Model Catalog: 523700 (Lot serial: M
  • Description du dispositif
    HEMOCLIP PLUS SML MED & LG
  • Manufacturer

Manufacturer