Events

Recall of LIFESTYLES SKYN ELITE

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

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
    44418
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-25
  • 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
    On august 21 ansell healthcare products llc was advised that a retail customer had received the referenced product with english only (us) package labeling. the customer also received english/french (canada) packages as well. the english only packaging was us market product labeling and not the carton labeling specific to canada. the us package labeling is in english does not contain french labeling and does contain all required label elements required under iso 4074 - natural rubber latex male condoms - requirement and test methods. this standard to which ansell attested compliance to under the original license outlines the requirements for labeling.

Device

LIFESTYLES SKYN ELITE

Manufacturer

ANSELL HEALTHCARE PRODUCTS LLC
  • Manufacturer Address
    DOTHAN
  • Manufacturer Parent Company (2017)
    Ansell Ltd.
  • Source
    HC