Events

Field Safety Notices about Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by N/A.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2005(02)
  • Date
    2005-03-14
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/durex-extra-safe-12-pack-condoms-and-durex-fetherlite-12-pack-condoms&id=639af825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Extra notes in the data
  • Reason
    The two above specified batches of condoms bearing the durex brand name are counterfeit products that do not meet the requirements of the european standard for condoms.
  • Action
    The IMB advises that you: Check both the outer packet and the condom foil to see if the details given above are the  same as those outlined on the product in your possession. If you have identified that you have product with the details above return any such affected product in your possession to your local pharmacy. If you think you may have used the affected condoms and have any health concerns, please consult your General Practitioner for their advice. Please be advised that this notice only applies to the 12 pack size of condoms specified above and not to any other pack size.

Device

Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Model / Serial
    Product Name:        Durex Extra Safe 12 Pack Condoms Batch Number:        20602503 Expiry Date:            2007/11 Product Name:        Durex Fetherlite 12 Pack Condoms Batch Number:        VR3073 U / VR3073 C / VR3073 E / VR3073 € Expiry Date:            2008/02
  • Product Description
    Durex Extra Safe 12 Pack Condoms and Durex Fetherlite 12 Pack Condoms
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    HPRA