Events

Rappel de ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER

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
    28745
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2004-12-06
  • 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
    Certain lots of the ez-et product codes exhibit a structeral feature that may cause incomplete staple line to be formed and therefore not previde expected control of the tissue.

Device

ENDOPATH ENDOSCOPIC RELOADABLE LINEAR CUTTER
  • Modèle / numéro de série
    Model Catalog: EZ45B (Lot serial: AND V); Model Catalog: EZ45G (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: EZ45B (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: EZ45G (Lot serial: V43C6F V43D7G); Model Catalog: EZ45B (Lot serial: V43C6F V43D7G); Model Catalog: EZ45G (Lot serial: V43D7H V43A0M V43A82); Model Catalog: EZ45B (Lot serial: V43D7H V43A0M V43A82); Model Catalog: EZ45G (Lot serial: EXCEPT V43A79 V43C6M); Model Catalog: EZ45B (Lot serial: EXCEPT V43A79 V43C6M); Model Catalog: EZ45G (Lot serial: AND V); Model Catalog: ET45B (Lot serial: V43C6M V43D7H V43A0M); Model Catalog: ET45B (Lot serial: EXCEPT V43A79); Model Catalog: ET45G (Lot serial: AND V); Model Catalog: ET45B (Lot serial: AND V); Model Catalog: ET45G (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: ET45B (Lot serial: ALL LOTS BEGINNING WITH T); Model Catalog: ET45G (Lot serial: V43C6M V43D7H V43A0M); Model Catalog: ET45B (Lot serial: V43A82 V43C6F V43D7G); Model Catalog: ET45G (Lot serial: V43A82 V43C6F V43D7G); M
  • Description du dispositif
    ENDOPATH THORACIC ELC ENDO. LINEAR CUT.
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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