Events

Rappel de INVACARE PEDIATRIC FLOWMETER ACCESSORY

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

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
    109777
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-06-23
  • 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 rear gradation scale was screen printed upside down on the flowmeter gauge. proper delivery of oxygen is critical to infants. in the population at greatest risk i.E. pediatric population health impact specific to high oxygen saturation could result in systemic toxicity potential lung vascular injury or over extended period of time could cause blindness.

Device

INVACARE PEDIATRIC FLOWMETER ACCESSORY
  • Modèle / numéro de série
    Model Catalog: IRCPF16AW (Lot serial: 16BF017557); Model Catalog: IRCPF16 (Lot serial: 16BF017557); Model Catalog: IRCPF16AW (Lot serial: 16DF040094); Model Catalog: IRCPF16 (Lot serial: 16DF040094); Model Catalog: IRCPF16AW (Lot serial: 16CF040083); Model Catalog: IRCPF16 (Lot serial: 16CF040083); Model Catalog: IRCPF16 (Lot serial: 16CF040071); Model Catalog: IRCPF16 (Lot serial: 16CF030121); Model Catalog: IRCPF16AW (Lot serial: 16CF030112); Model Catalog: IRCPF16 (Lot serial: 16CF030112); Model Catalog: IRCPF16AW (Lot serial: 16CF032024); Model Catalog: IRCPF16 (Lot serial: 16CF032024); Model Catalog: IRCPF16AW (Lot serial: 16CF040071); Model Catalog: IRCPF16AW (Lot serial: 16CF030121)
  • Description du dispositif
    INVACARE PRECISE RX PEDIATRIC FLOWMETER
  • Manufacturer
    INVACARE CORPORATION

Manufacturer

INVACARE CORPORATION