Events

Rappel de MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAYER MEDICAL CARE 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
    55073
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-10-05
  • 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
    In november 2015 during a review of historical intego sas testing it was discovered that documented test evidence related to 85 psi for 35 seconds could not be found. when the necessary testing was recently conducted some failures were found at three year simulated age testing. the failed samples exhibited leaks in the coil bond joint. there was no test failures of the samples at one year accelerated age. product is currently labeled with a 3 year shelf-life and thus needs to be corrected until this shelf-life can be re- established.

Device

MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET
  • Modèle / numéro de série
    Model Catalog: INT CSS (Lot serial: More than 10-contact manuf.)
  • Description du dispositif
    MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINI
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Adresse du fabricant
    PITTSBURGH
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    HC