Events

Rappel de INLINE VALVE WITH ACCESSORIES AND UNITIZED BACTISEAL CATHETER

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
    34782
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-07-21
  • 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
    As stated in the codman programmable valve ifu the virtual off setting (setting 8) is intended to limit flow through the valve and has an average pressure greater than 400mm h2o. recent in-vitro testing of the virtual off setting showed that the operating pressure for an individual valve may fall below 400mm h2o. this may result in a delay in treatment for shunt-related complications.

Device

INLINE VALVE WITH ACCESSORIES AND UNITIZED BACTISEAL CATHETER
  • Modèle / numéro de série
    Model Catalog: 82-8803 (Lot serial: ALL LOTS); Model Catalog: 82-8804 (Lot serial: CNLCW4); Model Catalog: 82-8804 (Lot serial: CPBB3H); Model Catalog: 82-8802 (Lot serial: ALL LOTS); Model Catalog: 82-8804 (Lot serial: CNPB1V); Model Catalog: 82-8804 (Lot serial: CNNDH3); Model Catalog: 82-8804 (Lot serial: CNMDM3); Model Catalog: 82-8804 (Lot serial: CPBCR0); Model Catalog: 82-8805 (Lot serial: ALL LOTS); Model Catalog: 82-8801 (Lot serial: ALL LOTS); Model Catalog: 82-8806 (Lot serial: ALL LOTS); Model Catalog: 82-8800 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 82-8807 (Lot serial: ALL LOTS)
  • Description du dispositif
    INLINE VALVE UNIT. BACTISEAL CATHACC.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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