Events

Recall of MEDICINE CUP 30ML

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67963
  • Event Risk Class
    III
  • Event Initiated Date
    2016-11-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    Model Catalog: DYND70000 (Lot serial: ALL LOTS BEFORE LOT#122212515)
  • Product Description
    DYND70000 MEDICINE CUP 30 ML
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION