Events

Rappel de BURR - DIAMOND BALL

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD..

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
    117891
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2006-01-18
  • 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
    The seal between the white polyethylene (hdpe/eva) and the clear polyethylene (ldpe/pet) layers of the pouch could be incomplete (a void) compromising the sterile barrier.

Device

BURR - DIAMOND BALL
  • Modèle / numéro de série
    Model Catalog: S-6D (Lot serial: 309740); Model Catalog: S-5D (Lot serial: 309740); Model Catalog: S-3D (Lot serial: 309740); Model Catalog: S-2D (Lot serial: 309740); Model Catalog: M-3D (Lot serial: 309740); Model Catalog: AND MORE (Lot serial: 50463390); Model Catalog: S-6D (Lot serial: 50463390); Model Catalog: S-5D (Lot serial: 50463390); Model Catalog: S-3D (Lot serial: 50463390); Model Catalog: S-2D (Lot serial: 50463319); Model Catalog: M-3D (Lot serial: 50463319); Model Catalog: AND MORE (Lot serial: 310128); Model Catalog: S-6D (Lot serial: 310128); Model Catalog: S-5D (Lot serial: 310128); Model Catalog: S-3D (Lot serial: 310128); Model Catalog: S-2D (Lot serial: 50463390); Model Catalog: M-3D (Lot serial: 50463390); Model Catalog: AND MORE (Lot serial: 50484904); Model Catalog: S-6D (Lot serial: 50484904); Model Catalog: S-5D (Lot serial: 50484904); Model Catalog: S-3D (Lot serial: 50484904); Model Catalog: S-2D (Lot serial: 50484904); Model Catalog: M-3D (Lot serial: 50484904); Model Catalog: AN
  • Description du dispositif
    BURR - DIAMOND BALL
  • Manufacturer
    ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD.

Manufacturer

ADVANCED SURGI-PHARM/BATRIK MEDICAL MFG./IMPERIAL SURGICAL LTD.
  • Adresse du fabricant
    DORVAL
  • Source
    HC