Events

Rappel de PRESSURE INJECTABLE PICC KIT

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par TELEFLEX MEDICAL 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
    89072
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-07-26
  • 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
    Arrow international is recalling the referenced product because these finished good kits may contain incorrect components. kits that should contain a 5 fr 2-lumen catheter may contain a 4 fr single lumen catheter and kits that should contain a 4 fr single lumen catheter may contain a 5 fr 2-lumen catheter. this labeling issue may cause a delay in treatment while a replacement catheter is obtained.

Device

PRESSURE INJECTABLE PICC KIT
  • Modèle / numéro de série
    Model Catalog: CDA-35041-HPK1A (Lot serial: 23F16F0614); Model Catalog: PR-35041-HPHNM (Lot serial: 13F17B0290); Model Catalog: CDC-35052-VPS (Lot serial: 13F17B0290); Model Catalog: CDC-35041-VPS (Lot serial: 13F17B0290); Model Catalog: CDA-35041-HPK1A (Lot serial: 13F17B0290); Model Catalog: PR-35041-HPHNM (Lot serial: 13F16A0180); Model Catalog: CDC-35052-VPS (Lot serial: 13F16A0180); Model Catalog: CDC-35041-VPS (Lot serial: 13F16A0180); Model Catalog: CDA-35041-HPK1A (Lot serial: 13F16A0180); Model Catalog: PR-35041-HPHNM (Lot serial: 13F16A0089); Model Catalog: CDC-35052-VPS (Lot serial: 13F16A0089); Model Catalog: CDC-35041-VPS (Lot serial: 13F16A0089); Model Catalog: CDA-35041-HPK1A (Lot serial: 13F16A0089); Model Catalog: PR-35041-HPHNM (Lot serial: 23F16M0059); Model Catalog: CDC-35052-VPS (Lot serial: 23F16M0059); Model Catalog: CDC-35041-VPS (Lot serial: 23F16M0059); Model Catalog: CDA-35041-HPK1A (Lot serial: 23F16M0059); Model Catalog: PR-35041-HPHNM (Lot serial: 23F17A0040); Model Catalog: CDC
  • Description du dispositif
    PRESSURE INJECTABLE PICC KIT
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.