Events

Rappel de HOLMIUM LASER FIBER MULTI USE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par COOK (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
    26215
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-04-13
  • 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
    The reprocessing instructions may not provide sufficiently detailed information for the cleaning disinfection and sterilization of these products. our preliminary investigation indicates that validation data related to the reprocessing of these devices may not meet current standards. there have been no reports of adverse reactions related to inadequate cleaning disinfection or sterilization associated with these devices.

Device

HOLMIUM LASER FIBER MULTI USE
  • Modèle / numéro de série
    Model Catalog: HLF-S940-H30 (Lot serial: U2424859); Model Catalog: FVO-150 (Lot serial: 5346681); Model Catalog: HLF-M365-HSMA (Lot serial: U2424859); Model Catalog: HLF-M273-HSMA (Lot serial: U2424859); Model Catalog: HLF-M365-H30 (Lot serial: U2424859); Model Catalog: HLF-M273-H30 (Lot serial: U2424859); Model Catalog: HLF-S940-H30 (Lot serial: U2319809); Model Catalog: HLF-M550-HSMA (Lot serial: U2319809); Model Catalog: HLF-M365-HSMA (Lot serial: U2319809); Model Catalog: HLF-M273-HSMA (Lot serial: U2319809); Model Catalog: HLF-M365-H30 (Lot serial: U2319809); Model Catalog: HLF-M273-H30 (Lot serial: U2319809); Model Catalog: HLF-S940-H30 (Lot serial: U2319808); Model Catalog: HLF-M550-HSMA (Lot serial: U2319808); Model Catalog: HLF-M365-HSMA (Lot serial: U2319808); Model Catalog: HLF-M273-HSMA (Lot serial: U2319808); Model Catalog: HLF-M365-H30 (Lot serial: U2319808); Model Catalog: HLF-M273-H30 (Lot serial: U2319808); Model Catalog: HLF-S940-H30 (Lot serial: U2319807); Model Catalog: HLF-M550-HSMA (Lot
  • Description du dispositif
    HOLMIUM LASER FIBER MULTI USE;VUEOPTIC VISUALIZATION SOURCE;FLEXOR VUE DEFLECTING ENDOSCOPIC SYSTEM
  • Manufacturer
    COOK (CANADA) INC.

Manufacturer

COOK (CANADA) INC.