Events

Rappel de HEMACAROTID ULTRATHIN KNITTED COLLAGEN COATED VASCULAR PATCH

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BARD CANADA 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
    112321
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2004-01-08
  • 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
    Quality testing performed at the manufacturing facility revealed a slightly higher degree of permeability than that req'd by our specification (5ml/cm2/min @ 120 mm hg).

Device

HEMACAROTID ULTRATHIN KNITTED COLLAGEN COATED VASCULAR PATCH
  • Modèle / numéro de série
    Model Catalog: HEK10/150CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK06/75 CPUT (Lot serial: 03G03 03H08 03J25); Model Catalog: HEK25/100CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK08/120 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK12/75CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK14/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK10/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK08/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK06/75 CPUT (Lot serial: 03G21 03J18 03J23); Model Catalog: HEK10/150CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK25/100CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK08/120 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK12/75CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK14/75 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK10/75 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK08/75 CPUT (Lot serial: 03G24 03J11 03K16); Model Catalog: HEK06/75 CPUT (L
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.