Events

Rappel de ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET

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
    46302
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-12-22
  • 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 this product because the packaging may not be completely sealed. if the packaging is compromised in this manner the sterility of the product cannot be guaranteed. if a non-sterile product is used there is potential for infection to occur.

Device

ARROW-HOWES MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION SET
  • Modèle / numéro de série
    Model Catalog: ASK-15703-PRJ (Lot serial: 13F17D0112); Model Catalog: ASK-15703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17B0279); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17F0575); Model Catalog: ASK-15703-PRJ (Lot serial: 13F17F0575); Model Catalog: ASK-12703-PRJ (Lot serial: 13F17D0112); Model Catalog: CDA-21242-1A (Lot serial: 13F17F0437); Model Catalog: CDA 42802-P1A (Lot serial: 13F17D0039); Model Catalog: CA-42703-P1A (Lot serial: 13F17D0039); Model Catalog: CDA-42703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA-45703-P1A (Lot serial: 13F17C0266); Model Catalog: CA-45703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA 42802-P1A (Lot serial: 13F17C0266); Model Catalog: CA-42703-P1A (Lot serial: 13F17C0266); Model Catalog: CDA-42703-P1A (Lot serial: 13F17A0301); Model Catalog: CDA-45703-P1A (Lot serial: 13F17A0301); Model Catalog: CA-45703-P1A (Lot serial: 13F17A0301); Model Catalog: CDA 42802-P1A (Lot serial: 13F17A0301); Model Catalog: CA-42703-P1A (Lot seria
  • Description du dispositif
    PERCUTANEOUS SHEATH INTRODUCER SET WITH ARROWG+ARD BLUE SHEATH;ARROWG+ARD BLUE MAC TWO-LUMEN CENTRAL VENOUS ACCESS KIT;AGB+ PRESSURE INJECTABLE MULTI-LUMEN CVC KIT;ERCUTANEOUS SHEATH INTRODUCER KIT WITH ARROWG+ARD BLUE(R) SHEATH INTEGRAL HEMOSTASIS VALVE/
  • Manufacturer
    TELEFLEX MEDICAL CANADA INC.

Manufacturer

TELEFLEX MEDICAL CANADA INC.