Events

Rappel de REALIZE (GENERATION 2) GASTRIC BAND WITH INJECTION PORT AND APPLIER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    97170
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2010-10-08
  • 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 manufacturer has received reports of the tubing strain relief component of the realize injection port becoming displaced from the locking connector and in some cases migrating from its original position on the locking connector. displacement of the strain relief component may result in kinking of the catheter which may prevent adjustment of fluid volume potentially rendering the product ineffective and requiring additional surgery to correct. in addition the strain relief component may migrate and become a foreign body within the abdomen which may require surgery to remove. implanted devices do not need to be removed because of this recall.

Device

REALIZE (GENERATION 2) GASTRIC BAND WITH INJECTION PORT AND APPLIER
  • Modèle / numéro de série
    Model Catalog: BD2XV (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: BD3XV (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: PT2XV (Lot serial: >10 NUMBERS CONTACT MFR)
  • Description du dispositif
    REALIZE ADJUSTABLE GASTRIC BAND
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.