Events

Rappel de MINOR SURGERY 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
    108121
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2012-10-22
  • 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
    Some presource packs kits and modules may not contain the temperature storage statement advising to store product at room temperature (15-30) on the product labeling. the missing temperature and storage information relates to the drugs in the kits and poses no threat or safety issue for the customer. all manufactured product has been stored appropriately during and after manufacture and distribution.

Device

MINOR SURGERY PACKS
  • Modèle / numéro de série
    Model Catalog: SBA30MAWRF (Lot serial: 117625); Model Catalog: SAN30LIKGB (Lot serial: 116963); Model Catalog: SAN30PAVHE (Lot serial: 116982); Model Catalog: SCV30PCKGG (Lot serial: 116982); Model Catalog: SAN30LIKGB (Lot serial: 116982); Model Catalog: SAN30PAVHE (Lot serial: 117513); Model Catalog: SCV30PCKGG (Lot serial: 117513); Model Catalog: SAN30LIKGB (Lot serial: 117513); Model Catalog: SAN30CADGI (Lot serial: 117927); Model Catalog: SAN30PAVHE (Lot serial: 116963); Model Catalog: PW30PLPM2 (Lot serial: 116012); Model Catalog: SOP30MNLSC (Lot serial: 116985); Model Catalog: SOP30FHJTF (Lot serial: 117059); Model Catalog: SOP30PHPBC (Lot serial: 117059); Model Catalog: SOP30HPRGH (Lot serial: 117059); Model Catalog: SOP30HPSTD (Lot serial: 117059); Model Catalog: SOP30FHJTF (Lot serial: 117754); Model Catalog: SOP30PHPBC (Lot serial: 117754); Model Catalog: SOP30HPRGH (Lot serial: 117754); Model Catalog: SOP30HPSTD (Lot serial: 117754); Model Catalog: SOP30FHJTF (Lot serial: 117628); Model Catalog: S
  • Description du dispositif
    MINOR SURGERY PACKS
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

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