Events

Rappel de CATH LAB INTERVENT'L SUPER ARROW-FLEX PERCUT SHEATH INTRO SETS - ADULT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED).

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
    49269
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2009-03-03
  • 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
    Material used in the manufacture of these products is not lipid resistant and could be weakened during the administration of lipid solution.

Device

CATH LAB INTERVENT'L SUPER ARROW-FLEX PERCUT SHEATH INTRO SETS - ADULT
  • Modèle / numéro de série
    Model Catalog: CP-07511 (Lot serial: ); Model Catalog: CL-08503 (Lot serial: ); Model Catalog: CL-08403 (Lot serial: ); Model Catalog: IC-09880 (Lot serial: ); Model Catalog: CW-08803 (Lot serial: ); Model Catalog: CW-08703 (Lot serial: ); Model Catalog: CP-08903 (Lot serial: ); Model Catalog: CP-08803 (Lot serial: ); Model Catalog: CP-08703 (Lot serial: ); Model Catalog: CP-08603-P (Lot serial: ); Model Catalog: CP-08603 (Lot serial: ); Model Catalog: CP-08503 (Lot serial: ); Model Catalog: CP-08403 (Lot serial: ); Model Catalog: CL-08803 (Lot serial: ); Model Catalog: CL-08703 (Lot serial: ); Model Catalog: CL-08605-HF (Lot serial: ); Model Catalog: CL-08605 (Lot serial: ); Model Catalog: CL-08603 (Lot serial: ); Model Catalog: CL-08503-A (Lot serial: ); Model Catalog: CL-08705-HF (Lot serial: ); Model Catalog: W20027 (Lot serial: ); Model Catalog: W-19922 (Lot serial: ); Model Catalog: W-15549 (Lot serial: ); Model Catalog: SC-00001 (Lot serial: ); Model Catalog: AI-7155-IK (Lot serial: ); Model Catalog:
  • Description du dispositif
    Percutaneous Sheath Introducer Sets
  • Manufacturer
    ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)

Manufacturer

ARROW INTERNATIONAL INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)