Events

Rappel de INCA REPLACEMENT SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOPERSURGICAL 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
    134000
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2010-07-27
  • 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
    As a result of coopersurgical's voluntary recall for the infant nasal cannulae (cpap)(inca) assembly the classification of the device was reviewed by health canada. subsequently coopersurgical is recalling the inca since it was sold in canada without a license.

Device

INCA REPLACEMENT SET
  • Modèle / numéro de série
    Model Catalog: 44-0715 (Lot serial: > 10 contact manufacturer); Model Catalog: 44-0712 (Lot serial: > 10 contact manufacturer); Model Catalog: 44-0710 (Lot serial: > 10 contact manufacturer); Model Catalog: 44-0709 (Lot serial: > 10 contact manufacturer); Model Catalog: 44-0707 (Lot serial: > 10 contact manufacturer); Model Catalog: 44-0715 (Lot serial: >10 contact mfg); Model Catalog: 44-2715 (Lot serial: >10 contact manufacturer); Model Catalog: 44-2712 (Lot serial: >10 contact manufacturer); Model Catalog: 44-2710 (Lot serial: >10 contact manufacturer); Model Catalog: 44-2709 (Lot serial: >10 contact manufacturer); Model Catalog: 44-2707 (Lot serial: >10 contact manufacturer); Model Catalog: 44-2715 (Lot serial: >10 contact mfg); Model Catalog: 44-2712 (Lot serial: >10 contact mfg); Model Catalog: 44-2710 (Lot serial: >10 contact mfg); Model Catalog: 44-2709 (Lot serial: >10 contact mfg); Model Catalog: 44-2707 (Lot serial: >10 contact mfg); Model Catalog: 44-0707 (Lot serial: >10 contact mfg); Model Cata
  • Description du dispositif
    INCA Infant Nasal Cannulae Assembly for CPAP Replacement Set
  • Manufacturer
    COOPERSURGICAL INC.

Manufacturer

COOPERSURGICAL INC.