Rappel de SAM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par FERNO 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
    129491
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-09-18
  • 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
    Sam medical is voluntarily recalling the sam junctional tourniquet (sjt) auxiliary (accessory) strap which is intended for use in the control of difficult bleeds in the axilla area. only the auxiliary strap is affected. the remaining components of the sjt are not impacted by this recall and function as intended. it was determined through customer feedback and subsequent internal testing that the rear retaining clip failed in a very small number of devices during training demonstrations. no report of patient injury nor has the device been reported to fail during actual patient use.

Device

  • Modèle / numéro de série
    Model Catalog: SJT 102 (Lot serial: 5/15/13)
  • Description du dispositif
    AM JUNCTIONAL TOURNIQUET 2 TARGET COMPRESSION DEVICES (1 WITH EXTENDER) HAND PUMP AUXILIARY STRAP
  • Manufacturer

Manufacturer