Events

Recall of Device Recall LifeStyles Pleasure Collection Condoms

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    63873
  • Event Risk Class
    Class 2
  • Event Number
    Z-0717-2013
  • Event Initiated Date
    2012-11-05
  • Event Date Posted
    2013-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114941
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Condom - Product Code HIS
  • Reason
    One lot of lifestyles pleasure collection lubricated condoms is misbranded. ultra thin was included rather than skyn.
  • Action
    Ansell Healthcare Products LLC sent an "URGENT: VOLUNTARY CONDOM RECALL" letter/return response form dated November 5, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm's Customer Service Department at 1-800-305-1054 for questions or if additional information is needed.

Device

Device Recall LifeStyles Pleasure Collection Condoms
  • Model / Serial
    Lot Code: 120921021C
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Lifestyles Pleasure Collection || 30 Premium Lubricated Condoms || Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. || UPC 0-70907-02625-0.
  • Manufacturer
    Ansell Healthcare Products LLC

Manufacturer

Ansell Healthcare Products LLC
  • Manufacturer Address
    Ansell Healthcare Products LLC, 1635 Industrial Rd, Dothan AL 36303-5750
  • Manufacturer Parent Company (2017)
    Ansell Ltd.
  • Source
    USFDA