Events

Rappel de POWERPICC SOLO2 CATHETER SHERLOCK STYLET AND MICROINTRODUCER

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
    125403
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2015-03-20
  • 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
    Bard has notified customers of the potential for scalpel cut/stick injury following a change in the safety scalpel component in some bard peripherally inserted central catheter (picc) kits. for users accustomed to the previous scalpel (bard-parker safety scalpel) a risk of improper use of the new safe-cut safety scalpel was noted. the customer letter described important differences in operation between the previous and current scalpel products.

Device

POWERPICC SOLO2 CATHETER SHERLOCK STYLET AND MICROINTRODUCER
  • Modèle / numéro de série
    Model Catalog: 1396118 (Lot serial: REYD0312); Model Catalog: 1295118 (Lot serial: REYD0312); Model Catalog: 1194118 (Lot serial: REYD0312); Model Catalog: 1396118 (Lot serial: REYD0126); Model Catalog: 1295118 (Lot serial: REYD0126); Model Catalog: 1194118 (Lot serial: REYD0126); Model Catalog: 1396118 (Lot serial: REYF0212); Model Catalog: 1295118 (Lot serial: REYF0212); Model Catalog: 1194118 (Lot serial: REYF0212); Model Catalog: 1396118 (Lot serial: REYE2229); Model Catalog: 1295118 (Lot serial: REYE2229); Model Catalog: 1194118 (Lot serial: REYE2229); Model Catalog: 1396118 (Lot serial: REYE1795); Model Catalog: 1295118 (Lot serial: REYE1795); Model Catalog: 1194118 (Lot serial: REYE1795); Model Catalog: 1396118 (Lot serial: REYD2021); Model Catalog: 1295118 (Lot serial: REYD2021); Model Catalog: 1194118 (Lot serial: REYD2021); Model Catalog: 1396118 (Lot serial: REYD1015); Model Catalog: 1295118 (Lot serial: REYD1015); Model Catalog: 1194118 (Lot serial: REYD1015); Model Catalog: 1396118 (Lot serial:
  • Description du dispositif
    POWERPICC SOLO2 WITH SHERLOCK STYLET
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.