My HPRA: Register

'Tulip' Condoms

Notice type: Advisory

Date: 09/06/2005

  

Product name or type:
'Tulip' Condoms

Reference:
SN2005(03)

Target Audience:
Consumer Public

Problem Or Issue:
  • These products do not carry a CE mark. 
  • The labelling of the condoms is in the Chinese language and not in the English language   as required by the national medical devices regulations.

Background Information Or Related Documents:
It has come to the attention of the Irish Medicines Board (IMB) that a brand of condoms bearing the “Tulip” brand name has been illegally imported into Ireland and has been placed on the Irish market.  These products have been sold to the public by a vendor on Moore Street in Dublin.    

These products are classified as medical devices under the Medical Devices Directive 93/42/EEC, Article 1, 2(a) and the related S.I. No. 252 of 1994 European Communities (Medical Devices) Regulations, 1994.  These condoms do not carry a CE mark in line with the legislation.  In order to place a medical device on the Irish market the manufacturer / authorised representative is required to CE mark the product.   

As the condoms have not been verified against CE marking requirements it cannot be confirmed if these condoms provide an effective barrier and therefore they cannot be guaranteed to prevent transmission of sexually transmitted diseases or work as an effective means of contraception.   

A recall of these condoms is underway.

'Tulip' Condoms Document

Actions To Be Taken:

The IMB advises that you: 

  • Check if you have 'Tulip' condoms in your possession.
  • If you have identified that you have these products you should dispose of these products immediately.
  • If you think you may have used these condoms and have any health concerns, please consult your General Practitioner for their advice.

Further Information:
If you have any enquiries relating to the above you may contact the Medical Devices Department of the Health Products Regulatory Authority at:   

Health Products Regulatory Authority
Medical Devices Department 
Kevin O'Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

Telephone:   01-6764971 
Fax:             01-6344033 
Email:          medicaldevices@imb.ie

SN2005(03): 'Tulip' Condoms

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