Events

Rappel de PRISMA SET/PRE SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par CARDINAL HEALTH 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
    44891
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-30
  • 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
    These conditions may occur when liquid is present on the male or female parts of the luer connector before connection (resulting for example from use of disinfectant or drops of priming or dialysate solution) and the wet connector is screwed by using the body of the luer connectors for tightening instead of screwing the coupling nut. under these circumstances the fluid on the cone can act as a lubricant and might lead to an over-tightening of the connection. the resulting luer connection may be difficult to disconnect and the male luer lock may break when applying a high mechanical force.

Device

PRISMA SET/PRE SET
  • Modèle / numéro de série
    Model Catalog: PRISMA TPE2000 SET (Lot serial: ALL LOTS); Model Catalog: PRISMA ST60 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMA ST100 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMA M100 PRE SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF20 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST100 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST60 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX ST150 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M60 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M150 SET (Lot serial: ALL LOTS); Model Catalog: OXIRIS (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF1400 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX HF1000 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX M100 SET (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX TPE 2000 (Lot serial: ALL LOTS); Model Catalog: PRISMAFLEX TPE 1000 (Lot serial: ALL LOTS)
  • Description du dispositif
    PRISMA SET
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    HC