Recall of CONTEMPO CONDOM - INTENSITY (LUBRICATED)

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

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
    33048
  • Event Risk Class
    II
  • Event Initiated Date
    2002-12-09
  • Event Country
  • 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
    Condoms failed the air bust bust volume test.

Device

  • Model / Serial
    Model Catalog: (Lot serial: 7750200 10750500 101752500); Model Catalog: (Lot serial: 9994022 911703722 4991122); Model Catalog: (Lot serial: 9994022 9994422 911703722); Model Catalog: (Lot serial: ); Model Catalog: (Lot serial: 9994522 9995322 9995422); Model Catalog: (Lot serial: 108750200 203750800 1991022)
  • Product Description
    CONTEMPO INTENSITY COLOURS LUB.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    COWANSVILLE
  • Manufacturer Parent Company (2017)
  • Source
    HC