Events

Rappel de S.M.A.R.T. FLEX BILIARY STENT SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARDINAL HEALTH 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
    65003
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • 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
    Based on one complaint and the subsequent investigation cordis has determined that selected lots of s.M.A.R.T. flex biliary stent system have a potential for cracked luer hubs due to a manufacturing error. the luer hub is used to inject contrast/saline during procedure preparation prior to insertion of the stent system into the patient. a cracked hub could result in leakage of saline or in the worst case inability to flush the outer sheath of the catheter.

Device

S.M.A.R.T. FLEX BILIARY STENT SYSTEM
  • Modèle / numéro de série
    Model Catalog: SF06100MB (Lot serial: 41322); Model Catalog: SF06120MB (Lot serial: 41322); Model Catalog: SF09060MB (Lot serial: 41322); Model Catalog: SF10060SB (Lot serial: 41322); Model Catalog: SF10040SB (Lot serial: 40997); Model Catalog: SF06120MB (Lot serial: 40997); Model Catalog: SF06100MB (Lot serial: 40997); Model Catalog: SF09100SB (Lot serial: 40997); Model Catalog: SF09060MB (Lot serial: 40997); Model Catalog: SF10060SB (Lot serial: 40997); Model Catalog: SF10040SB (Lot serial: 41353); Model Catalog: SF06120MB (Lot serial: 41353); Model Catalog: SF06100MB (Lot serial: 41353); Model Catalog: SF09100SB (Lot serial: 41353); Model Catalog: SF09060MB (Lot serial: 41353); Model Catalog: SF10060SB (Lot serial: 41353); Model Catalog: SF10040SB (Lot serial: 41318); Model Catalog: SF06120MB (Lot serial: 41318); Model Catalog: SF06100MB (Lot serial: 41318); Model Catalog: SF09100SB (Lot serial: 41318); Model Catalog: SF09060MB (Lot serial: 41318); Model Catalog: SF10060SB (Lot serial: 41318); Model Catal
  • Description du dispositif
    S.M.A.R.T. FLEX BILIARY STENT SYSTEM
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    HC