Events

Rappel de HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MCARTHUR MEDICAL SALES 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
    22980
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-27
  • 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
    Cracks in silicon extension tubing of hemodialysis catheters propagate over time resulting in holes because of inadequate use during the insertion procedure that is the extension line clamp is clamped onto the guidewire. the hole in the extension tubing leaks when the device is being pressurized with a syringe during flushing or during dialysis treatment.

Device

HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
  • Modèle / numéro de série
    Model Catalog: SL15E (Lot serial: ALL); Model Catalog: SL24P (Lot serial: ALL); Model Catalog: SL12P (Lot serial: ALL); Model Catalog: SL18P (Lot serial: ALL); Model Catalog: SL24C (Lot serial: ALL); Model Catalog: SL20C (Lot serial: ALL); Model Catalog: SL15C (Lot serial: ALL); Model Catalog: SL32 (Lot serial: ALL); Model Catalog: SL28 (Lot serial: ALL); Model Catalog: MC101241 (Lot serial: ALL); Model Catalog: SDL138E (Lot serial: ALL); Model Catalog: SDL136E (Lot serial: ALL); Model Catalog: MC101243 (Lot serial: ALL); Model Catalog: MC101242 (Lot serial: ALL); Model Catalog: SDL139E (Lot serial: ALL)
  • Description du dispositif
    HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
  • Manufacturer
    MCARTHUR MEDICAL SALES INC.

Manufacturer

MCARTHUR MEDICAL SALES INC.