Events

Rappel de PDS (POLYDIOXANONE) MONOFILAMENT SUTURE

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
    101134
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-02-04
  • 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
    Ethicon is conducting a recall of 21 lots and 19 corresponding product codes of absorbable sutures for which sterility cannot be assured due to a failure in the sterilization process.

Device

PDS (POLYDIOXANONE) MONOFILAMENT SUTURE
  • Modèle / numéro de série
    Model Catalog: Z969H (Lot serial: APM797); Model Catalog: Z320H (Lot serial: APM797); Model Catalog: Z117H (Lot serial: APM797); Model Catalog: VCPB340H (Lot serial: AP2599); Model Catalog: VCP602H (Lot serial: APZ372); Model Catalog: VCP534H (Lot serial: APZ372); Model Catalog: VCP416H (Lot serial: APZ372); Model Catalog: VCPB340H (Lot serial: APZ372); Model Catalog: VCP615H (Lot serial: APM982); Model Catalog: VCP602H (Lot serial: APM982); Model Catalog: VCP534H (Lot serial: APM982); Model Catalog: VCP416H (Lot serial: APM982); Model Catalog: VCPB340H (Lot serial: APM982); Model Catalog: VCP615H (Lot serial: APZ804); Model Catalog: VCP602H (Lot serial: APZ804); Model Catalog: VCP534H (Lot serial: APZ804); Model Catalog: VCP416H (Lot serial: APZ804); Model Catalog: VCPB340H (Lot serial: APZ804); Model Catalog: VCP615H (Lot serial: APM984); Model Catalog: VCP602H (Lot serial: APM984); Model Catalog: VCP534H (Lot serial: APM984); Model Catalog: VCP416H (Lot serial: APM984); Model Catalog: VCPB340H (Lot serial
  • Description du dispositif
    PDSII(POLYDIOXANONE)MONOFILAMENT SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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