Events

Rappel de SERATRONICS DIALYZER PREPARATION SYSTEM

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

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
    66314
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-01-13
  • 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
    Conmed received five complaints of some devices which had broken through the seal of the sterile pouch: the initial complaint was received on november 30 2012. conmed has confirmed instances where the pouch seal was compromised on the affected products. in no instance has it been reported to conmed corporation that a compromise in the sterile barrier has resulted in illness or injury. the compromised seals were discovered prior to use.

Device

SERATRONICS DIALYZER PREPARATION SYSTEM
  • Modèle / numéro de série
    Model Catalog: 130343 (Lot serial: 120628X - 120917X); Model Catalog: 138025 (Lot serial: 120628X - 120917X); Model Catalog: 137668 (Lot serial: 120628X - 120917X); Model Catalog: 139105EXT (Lot serial: 120628X - 120917X); Model Catalog: 139104EXT (Lot serial: 120628X - 120917X); Model Catalog: 139102 (Lot serial: 120628X - 120917X); Model Catalog: 139112 (Lot serial: 120628X - 120917X); Model Catalog: 7-100-8BX (Lot serial: 120628X - 120917X); Model Catalog: 7-101-8BX (Lot serial: 120628X - 120917X); Model Catalog: 139107 (Lot serial: 120628X - 120917X)
  • Description du dispositif
    Single Use ABC Nozzle Sterile (For use with 130500 Reusable ABC Handpiece)
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    HC