Rappel de SHER-I-BRONCH ENDOBRONCHIAL TUBE KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TRUDELL MEDICAL MARKETING LIMITED.

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
    137196
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2009-08-14
  • 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
    The tether attaching to the double swivel cap may partially or completely break at the attachent points. the brojen tether may lodge inside the dual swivel tubing or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the patient's lungs.

Device

  • Modèle / numéro de série
    Model Catalog: 5-16028 (Lot serial: < 10 lot numbers); Model Catalog: 5-15401 (Lot serial: < 10 lot numbers); Model Catalog: 5-15301 (Lot serial: < 10 lot numbers); Model Catalog: 5-15401 (Lot serial: contact manufacturer); Model Catalog: 5-15301 (Lot serial: contact manufacturer); Model Catalog: 5-16141 (Lot serial: contact manufacturer); Model Catalog: 5-16139 (Lot serial: contact manufacturer); Model Catalog: 5-16137 (Lot serial: contact manufacturer); Model Catalog: 5-16135 (Lot serial: contact manufacturer); Model Catalog: 5-16128 (Lot serial: contact manufacturer); Model Catalog: 5-16041 (Lot serial: contact manufacturer); Model Catalog: 5-16039 (Lot serial: contact manufacturer); Model Catalog: 5-16037 (Lot serial: contact manufacturer); Model Catalog: 5-16035 (Lot serial: contact manufacturer); Model Catalog: 5-16028 (Lot serial: contact manufacturer); Model Catalog: 5-16141 (Lot serial: < 10 lot numbers); Model Catalog: 5-16139 (Lot serial: < 10 lot numbers); Model Catalog: 5-16137 (Lot serial: < 10
  • Description du dispositif
    SHER-I-BRONCH
  • Manufacturer

Manufacturer