Events

Rappel de VEIN ACCESS CATHETER EXTENSION SETS WITH CLEARLINK VALVE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER CORPORATION.

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
    15913
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-04-09
  • 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
    Baxter corporation is initiating a lot-specific recall of some catheter extension sets and catheter extension set kits. the individual packages are distributed in strips separated by perforations. some customers have reported that when separating an individual package from its attached grouping the adjacent package has opened compromising its sterile barrier properties.

Device

VEIN ACCESS CATHETER EXTENSION SETS WITH CLEARLINK VALVE
  • Modèle / numéro de série
    Model Catalog: 2N8371 (Lot serial: R12I10113); Model Catalog: 2N1191 (Lot serial: R12J06052); Model Catalog: 2N1191 (Lot serial: R12J08041); Model Catalog: 2N1191 (Lot serial: R12K26108); Model Catalog: 2N3371 (Lot serial: R12I25046); Model Catalog: 2N3371 (Lot serial: R12H30097); Model Catalog: 2N3371 (Lot serial: R12J11052); Model Catalog: 2N3371 (Lot serial: R12I26077); Model Catalog: 2N3371 (Lot serial: R12H23076); Model Catalog: 2N3371 (Lot serial: R12J13058); Model Catalog: 2N3371 (Lot serial: R12I07077)
  • Description du dispositif
    CLEARLINK SYSTEM CATHETER EXTENSION SET
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION