Events

Rappel de MEDICINE CUP 30ML

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par MEDLINE CANADA CORPORATION.

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
    67963
  • Classe de risque de l'événement
    III
  • Date de mise en oeuvre de l'événement
    2016-11-25
  • 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 medicine cups have gradation markings on the side in millilitres. the increments are 2.5 5 7.5 10 12.5 15 20 25 30 ml. some cups repeat the 5 ml mark at the 10 ml location so that the increments appear as: 2.5 5 7.5 5 12.5 15 20 25 30 ml. therefore a certain number of cups in each case of product will have incorrect markings. the cups are injection molded on a machine that has 64 cavities (a cavity is a mold for a cup). therefore 64 cups can be produced at once with each injection of material. each cavity is numbered and the number is embossed on the bottom of the cup. cavity #44 is the defective mold with the incorrect increments. therefore every cup numbered #44 on the bottom will have the defect. the cups are packaged in sleeves of 100 stacked cups and packaged 500 stacks in a case (5000 cups). there will be 2 4 or 6 sleeves containing cups from cavity #44 in a case which comes out to 50-150 cups per case. this is based on how the robot stacks combines and bags the product. therefore there is the potential for 150 defective cups in a case.

Device

MEDICINE CUP 30ML
  • Modèle / numéro de série
    Model Catalog: DYND70000 (Lot serial: ALL LOTS BEFORE LOT#122212515)
  • Description du dispositif
    DYND70000 MEDICINE CUP 30 ML
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION