Events

Rappel de AMSCO EVOLUTION PREVACUUM STEAM STERILIZER

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

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
    76175
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2013-10-18
  • 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 amsco evolution steam sterilizers utilize a loading system to assist the operator in transporting loading and unloading items to be sterilized. off-label use of transfer carriages by customers is resulting in minor injuries such as strained backs. despite repeated in-services these injuries are occurring when operators are pushing/maneuvering carriages that have been overloaded or not loaded evenly.

Device

AMSCO EVOLUTION PREVACUUM STEAM STERILIZER
  • Modèle / numéro de série
    Model Catalog: UE44-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE43-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE26-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE25-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE24-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE06-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE05-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE04-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE42-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE41-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE23-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE22-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE21-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); Model Catalog: UE03-XXX-XXX-XXX (Lot serial: 030061103 thru 0535531220); M
  • Description du dispositif
    AMSCO EVOLUTION MEDIUM STEAM STERILIZER ACCESSORY-EVOLUTION TRANSFER CARRIAGE
  • Manufacturer
    STERIS CANADA INCORPORATED

Manufacturer

STERIS CANADA INCORPORATED
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Steris Plc
  • Source
    HC