Events

Rappel de COATED VICRYL RAPIDE 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
    22212
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-09-08
  • 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
    Manufacturer has identified that certain lots of sizes 2-0 and 4-0 for vicryl rapidet suture exhibited suture damage due to a manufacturing equipment issue. the manufacturing equipment issue has been corrected. the medical assessment concluded that this situation could result in a potential superficial wound dehiscence or contribute to impaired wound healing but only occasionally and/or under unusual circumstances. manufacturer has not received any reports of adverse events associated with the product subject to this recall.

Device

COATED VICRYL RAPIDE SUTURE
  • Modèle / numéro de série
    Model Catalog: VR496 (Lot serial: AH7686); Model Catalog: VR945 (Lot serial: AH7686); Model Catalog: VR2297 (Lot serial: AH7711); Model Catalog: VR496 (Lot serial: AH7711); Model Catalog: VR945 (Lot serial: AH7711); Model Catalog: VR2297 (Lot serial: AJ0770); Model Catalog: VR496 (Lot serial: AJ0770); Model Catalog: VR945 (Lot serial: AJ0770); Model Catalog: VR2297 (Lot serial: AJ0794); Model Catalog: VR496 (Lot serial: AJ0794); Model Catalog: VR945 (Lot serial: AJ0794); Model Catalog: VR2297 (Lot serial: AH7686); Model Catalog: VR945 (Lot serial: AH7680); Model Catalog: VR496 (Lot serial: AH7680); Model Catalog: VR2297 (Lot serial: AH7680); Model Catalog: VR945 (Lot serial: AH7694); Model Catalog: VR496 (Lot serial: AH7694); Model Catalog: VR496 (Lot serial: AH6611); Model Catalog: VR945 (Lot serial: AH6611); Model Catalog: VR2297 (Lot serial: AH7694); Model Catalog: VR2297 (Lot serial: AH6611)
  • Description du dispositif
    COATED VICRYL RAPIDE SUTURE
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

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