Events

Recall of LIFESTYLES SKYN COCKTAIL

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
    76899
  • Event Risk Class
    III
  • Event Initiated Date
    2018-03-05
  • 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 skyn cocktail club polyisoprene male condom label is inaccurate. affected lots inaccurately identify on the label swell usa as the manufacturer instead of the appropriate manufacturer ansell healthcare.

Device

LIFESTYLES SKYN COCKTAIL
  • Model / Serial
    Model Catalog: 9831 (Lot serial: 180206091C); Model Catalog: 9831 (Lot serial: 180116011C)
  • Product Description
    SKYN COCKTAIL CLUB POLYISOPRENE MALE CONDOM
  • Manufacturer
    ANSELL CANADA INC

Manufacturer

ANSELL CANADA INC
  • Manufacturer Address
    COWANSVILLE
  • Manufacturer Parent Company (2017)
    Ansell Ltd.
  • Source
    HC