Events

Rappel de DENTAL PROCEDURES PACKS

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
    46971
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2016-11-02
  • 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
    Cardinal health has been informed by medtronic of a medical device correction in regards to covidien devon light gloves contained in presource kits. this correction has been initiated to update labeling of the instructions for use. medtronic advises that on rare occasion the devon light glove may split upon application to the devon light handle adapter. a split in the glove can potentially lead to a breach in the sterile barrier between the glove and the handle adapter. the following statement will be added to the instructions for use to help or staff ensures that the sterile field is maintained "after application inspect the light glove for barrier integrity".

Device

DENTAL PROCEDURES PACKS
  • Modèle / numéro de série
    Model Catalog: SEN30DNHKI (Lot serial: 285533); Model Catalog: SEN30DNHKI (Lot serial: 305037); Model Catalog: SBA30BRUCB (Lot serial: 315310); Model Catalog: SBA30BRUCB (Lot serial: 438644); Model Catalog: SBA30BRUCB (Lot serial: 462499); Model Catalog: SBA30ABUCE (Lot serial: 384268); Model Catalog: SBA30ABUCE (Lot serial: 393264); Model Catalog: SBA30ABUCE (Lot serial: 501923); Model Catalog: SOP30XTHDB (Lot serial: 304160); Model Catalog: SEY30STHKF (Lot serial: 283188); Model Catalog: SCV30CCCHB (Lot serial: 266131); Model Catalog: SCV30CCCHB (Lot serial: 319081); Model Catalog: SCV30CCCHB (Lot serial: 386378); Model Catalog: SCV30CCCHB (Lot serial: 440217); Model Catalog: SCV30CCCHB (Lot serial: 571646); Model Catalog: SCV30CCCHB (Lot serial: 492916)
  • Description du dispositif
    STERILE DENTAL PACK;STERILE BREAST PACK;STERILE ABDOMINAL PACK;STERILE EXTREMITY PACK;STERILE STRABISMUS PACK;STERILE CARDIAC PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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