Events

Rappel de INTRADYN TEAR AWAY-SHEATH INTRODUCER SETS W/SPIN-LOCK ADAPTER (SINGLE SET)

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par B. BRAUN MEDICAL 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
    115670
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2005-06-08
  • 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
    Cie had reports of a tearaway introducer sheaths with craked hubs/handles and/or improper peeling of the sheath during use in a small percentage of products.

Device

INTRADYN TEAR AWAY-SHEATH INTRODUCER SETS W/SPIN-LOCK ADAPTER (SINGLE SET)
  • Modèle / numéro de série
    Model Catalog: (Lot serial: 60734898); Model Catalog: (Lot serial: 60521374); Model Catalog: (Lot serial: 60702179); Model Catalog: (Lot serial: 60722688); Model Catalog: (Lot serial: 60710159); Model Catalog: STA 8 (Lot serial: 60707368); Model Catalog: STA 16 (Lot serial: 60707368); Model Catalog: STA 5 (Lot serial: 60707368); Model Catalog: STA 9 (Lot serial: 60707368); Model Catalog: 610102 (Lot serial: 60707368); Model Catalog: 610152 (Lot serial: 60707368); Model Catalog: 333606 (Lot serial: 60707368); Model Catalog: 610652 (Lot serial: 60707368); Model Catalog: 333615A (Lot serial: 60707368); Model Catalog: 333612 (Lot serial: 60707368); Model Catalog: 333614 (Lot serial: 60707368); Model Catalog: 333603 (Lot serial: 60707368); Model Catalog: 333611 (Lot serial: 60707368); Model Catalog: 333613 (Lot serial: 60707368); Model Catalog: (Lot serial: 60708049); Model Catalog: (Lot serial: 60702094); Model Catalog: (Lot serial: 60551766); Model Catalog: (Lot serial: 60723081); Model Catalog: (Lot
  • Description du dispositif
    INTRADYN TEARAWAY SHEATH INTRODUCER SET
  • Manufacturer
    B. BRAUN MEDICAL INC.

Manufacturer

B. BRAUN MEDICAL INC.