Events

Rappel de PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SMITHS MEDICAL CANADA LTD. (SIMS).

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
    33305
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2005-05-24
  • 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
    Guiding catheters which have been discovered to have weakened sidewalls in the area around the black over molded "stop" which may compromise the devices resistance to breakage. the "stop" may become detached.

Device

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT
  • Modèle / numéro de série
    Model Catalog: 538090E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K518075 K520177 K548751); Model Catalog: 538080E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K510893); Model Catalog: 538090E (Lot serial: K510891 K510892 K565595); Model Catalog: 538080E (Lot serial: K510891 K510892 K565595); Model Catalog: 538070E (Lot serial: K510891 K510892 K565595); Model Catalog: 538090E (Lot serial: K586109 K614402 K629274); Model Catalog: 538080E (Lot serial: K586109 K614402 K629274); Model Catalog: 538070E (Lot serial: K586109 K614402 K629274); Model Catalog: 538090E (Lot serial: K515076 K518078 K558496); Model Catalog: 538080E (Lot serial: K515076 K518078 K558496); Model Catalog: 538070E (Lot serial: K515076 K518078 K558496); Model Catalog: 538090E (Lot serial: K559483 K614996 K630177); Model Catalog: 538080E (Lot serial: K559483 K614996 K630177); Model Catalog: 538070E (Lot serial: K559483 K614996 K630177); Model Catalog: 538090E (Lot serial: K523556 K527903 K548745); Model Catalog: 53
  • Description du dispositif
    portex perfit percutaneous dilational
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    HC