Events

Rappel de ORBIT MICRO SUBCUTANEOUS INFUSION SET

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par INSULINPUMPS.CA 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
    39245
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2011-04-18
  • 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
    Icu reported that certain lots of orbit 90 and orbit micro infusion sets may incur damage due to movement during shipping resulting in bent needles. the damage is easily detectible within the unopened sterile tray. if the needle cover is not attached to the needle and/or the needle is bent the device is damaged and should not be used.

Device

ORBIT MICRO SUBCUTANEOUS INFUSION SET
  • Modèle / numéro de série
    Model Catalog: P2451 (Lot serial: >10 Lot Numbers.); Model Catalog: P4251 (Lot serial: >10 Lot Numbers.); Model Catalog: P3051 (Lot serial: >10 Lot Numbers.); Model Catalog: P4291 (Lot serial: Contact manufacturer.); Model Catalog: P4261 (Lot serial: Contact manufacturer.); Model Catalog: P3091 (Lot serial: Contact manufacturer.); Model Catalog: P3061 (Lot serial: Contact manufacturer.); Model Catalog: P2491 (Lot serial: Contact manufacturer.); Model Catalog: P2461 (Lot serial: Contact manufacturer.); Model Catalog: P1891 (Lot serial: Contact manufacturer.); Model Catalog: P1861 (Lot serial: Contact manufacturer.); Model Catalog: M4291 (Lot serial: Contact manufacturer.); Model Catalog: M4261 (Lot serial: Contact manufacturer.); Model Catalog: M3091 (Lot serial: Contact manufacturer.); Model Catalog: M2491 (Lot serial: Contact manufacturer.); Model Catalog: M2461 (Lot serial: Contact manufacturer.); Model Catalog: M1861 (Lot serial: Contact manufacturer.); Model Catalog: P4291 (Lot serial: >10 lot numbers.);
  • Description du dispositif
    ORBIT MICRO SUBCUTANEOUS INFUSION SET
  • Manufacturer
    INSULINPUMPS.CA INC.

Manufacturer

INSULINPUMPS.CA INC.
  • Adresse du fabricant
    OAKVILLE
  • Source
    HC