Events

Rappel de RENASYS-G GAUZE DRESSING KIT WITH FLAT DRAIN

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par SMITH & NEPHEW 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
    63134
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-04-20
  • 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
    It has been determined that the wipes in the kits subject to this correction were made in the same facility as other wipe products including wipes swabs and swab sticks that are the subject of other voluntary recalls due to a potential bacterial contamination issue.

Device

RENASYS-G GAUZE DRESSING KIT WITH FLAT DRAIN
  • Modèle / numéro de série
    Model Catalog: 66800492 (Lot serial: 30310H); Model Catalog: 66800494 (Lot serial: 30310H); Model Catalog: 66800492 (Lot serial: 35510H); Model Catalog: 66800494 (Lot serial: 35510H); Model Catalog: 66800492 (Lot serial: 10310N); Model Catalog: 66800494 (Lot serial: 10310N); Model Catalog: 66800492 (Lot serial: 11410E); Model Catalog: 66800494 (Lot serial: 11410E); Model Catalog: 66800492 (Lot serial: 00811N); Model Catalog: 66800494 (Lot serial: 00811N); Model Catalog: 66800494 (Lot serial: 09510N); Model Catalog: 66800492 (Lot serial: 09510N); Model Catalog: 66800493 (Lot serial: 00811K); Model Catalog: 66800493 (Lot serial: 09510U); Model Catalog: 66800493 (Lot serial: 27210D); Model Catalog: 66800493 (Lot serial: 27710W); Model Catalog: 66800493 (Lot serial: 28410H); Model Catalog: 66800493 (Lot serial: 29210F); Model Catalog: 66800493 (Lot serial: 29210P); Model Catalog: 66800495 (Lot serial: 27810D); Model Catalog: 66800491 (Lot serial: 27810D); Model Catalog: 66800496 (Lot serial: 21010E); Model Catal
  • Description du dispositif
    RENASYS G GAUZE DRESSING KIT
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.