Events

Retiro De Equipo (Recall) de MEDICINE CUP 30ML

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDLINE CANADA CORPORATION.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67963
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-11-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    Model Catalog: DYND70000 (Lot serial: ALL LOTS BEFORE LOT#122212515)
  • Descripción del producto
    DYND70000 MEDICINE CUP 30 ML
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION